{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-13", "results": { "skip": 0, "limit": 1, "total": 2099 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "OUTPATIENT TREATMENT FACILITY", "report_to_fda": "Y", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "1000118068-2020-00020", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200528", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200515", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "report_date": "20200610", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "117", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "date_facility_aware": "20200516", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200528", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "561247", "implant_date_year": "2020", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200528", "brand_name": "RESTYLANE-L", "generic_name": "IMPLANT, DERMAL, FOR AESTHETIC USE", "manufacturer_d_name": "GALDERMA Q-MED AB", "manufacturer_d_address_1": "SEMINARIEGATAN 21", "manufacturer_d_address_2": "", "manufacturer_d_city": "UPPSALA,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "SE-75", "manufacturer_d_zip_code_ext": "228", "manufacturer_d_country": "SW", "manufacturer_d_postal_code": "SE-75228", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "16999", "other_id_number": "", "device_availability": "No", "device_report_product_code": "LMH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Implant, Dermal, For Aesthetic Use", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250811", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200528", "sequence_number_treatment": [ "DYSPORT", " DYSPORT", " RESTYLANE DEFYNE", " RESTYLANE DEFYNE", " RESTYLANE LYFT WITH LIDOCAINE", " RESTYLANE LYFT WITH LIDOCAINE", " VITAMIN D" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Erythema", "Pain", "Skin Discoloration", "Swelling", "Vascular System (Circulation), Impaired", "No Code Available", "Erythema", "Pain", "Skin Discoloration", "Swelling", "Vascular System (Circulation), Impaired", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200615", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "date_report_to_manufacturer": "20200602", "manufacturer_contact_city": "", "mdr_report_key": "10096718", "removal_correction_number": "", "number_devices_in_event": "", "date_report_to_fda": "20200610", "manufacturer_name": "", "report_source_code": "Distributor report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195237938", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "MANUFACTURER COMMENT: LOT NUMBER WAS NOT REPORTED. PHARMACOVIGILANCE COMMENT: THE SERIOUS EXPECTED EVENT OF VASCULAR OCCLUSION WAS CONSIDERED POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS. THE NON-SERIOUS EXPECTED EVENTS OF DISCOLOURATION, PAIN, SWELLING AT IMPLANT SITE AND UNEXPECTED EVENT OF POOR PERIPHERAL CIRCULATION WERE CONSIDERED POSSIBLY RELATED TO THE TREATMENT. POTENTIAL CONTRIBUTORY FACTOR INCLUDE INTRAVASCULAR FILLER INJECTION LEADING TO VASCULAR OCCLUSION AND SUBSEQUENT MANIFESTATIONS. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. CAPA COMMENT: THE INFORMATION IN THIS SINGLE CASE DOES NOT SUGGEST INVOLVEMENT OF A NONCONFORMING PRODUCT OR QUALITY PROBLEM AND WILL NOT INITIATE A CORRECTIVE OR PREVENTIVE ACTION." }, { "mdr_text_key": "195237939", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 16-MAY-2020 BY AN OTHER HEALTH PROFESSIONAL WHICH REFERS TO A FEMALE PATIENT OF AN UNKNOWN AGE. ADDITIONAL INFORMATION WAS RECEIVED ON 18-MAY-2020 FROM SAME REPORTER. NO INFORMATION ABOUT MEDICAL HISTORY, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6) 2020, THE PATIENT RECEIVED TREATMENT WITH RESTYLANE-L TO UPPER AND LOWER LIPS (UNKNOWN AMOUNT, LOT NUMBER, INJECTION TECHNIQUE AND NEEDLE TYPE). ON THE SAME DAY, PATIENT ALSO RECEIVED TREATMENT WITH RESTYLANE DEFYNE TO POSTERIOR JAW, NASOLABIAL FOLDS, MARIONETTE LINES AND RESTYLANE LYFT WITH LIDOCAINE TO RIGHT AND LEFT CHEEK, MIDFACE (UNKNOWN AMOUNT, LOT NUMBER, INJECTION TECHNIQUE AND NEEDLE TYPE) AND DYSPORT [DYSPORT] TO UPPER FOREHEAD, CROW'S FEET AND GLABELLA. PATIENT WAS INJECTED WITH RESTYLANE LYFT AND PROGRESSED TO THE RESTYLANE DEFYNE INJECTION. THE HCP REPORTED THAT SHE THEN INJECTED THE RESTYLANE-L TO THE LIPS STARTING WITH THE UPPER LIP, RIGHT SIDE AND PROGRESSING THE UPPER LEFT LIP AND THEN ON TO THE LOWER LIP. ON (B)(6) 2020, AFTER THE LIP INJECTION COMPLETED, THE HCP NOTED A FAINT RED LACY DISCOLORATION/SLIGHTLY DUSKY IN APPEARANCE(IMPLANT SITE DISCOLOURATION) TO THE RIGHT UPPER LIP AS WELL AS A MILD ASYMMETRIC SWELLING(IMPLANT SITE SWELLING) TO THE RIGHT SIDE OF THE UPPER LIP. THE HCP THEN WENT TO INJECT DYSPORT IN THE FOREHEAD, GLABELLA AND CROW'S FEET AREAS. AFTER COMPLETING THE DYSPORT INJECTION, HCP RE-ASSESSED THE LIP AREA AND NOTED THE ASYMMETRY PERSISTED AND THE RED LACY DISCOLORATION APPEARED TO BECOME SLIGHTLY DUSKY IN APPEARANCE AND HAD PROGRESSED TO INCLUDE SOME OF THE UPPER LEFT LIP. SLUGGISH CAPILLARY REFILL(POOR PERIPHERAL CIRCULATION) WAS NOTED. IT WAS REPORTED THAT PATIENT EXPERIENCED A VASCULAR OCCLUSION(VASCULAR OCCLUSION) FROM RESTYLANE-L INJECTED IN THE LIPS. AT THIS POINT THE HCP ELECTED TO INJECT WITH HYLENEX [HYALURONIDASE] MIXED WITH 2% LIDOCAINE [LIDOCAINE], APPROXIMATELY 300 UNITS TO THE UPPER LIP AREA. THE HCP FOLLOWED THE INJECTION OF HYLENEX WITH WARM COMPRESSES AND VIGOROUS MASSAGE. AFTER 15 MINUTES, THE HCP RE-CHECKED THE AREA AND DID NOT FEEL THERE WAS IMPROVEMENT. THE HYLENEX WAS REPEATED AS WELL AS THE WARM COMPRESSES AND MASSAGE. AFTER ANOTHER 15 MINUTES, THE PATIENT STILL HAD A DUSKY APPEARANCE TO THE UPPER LIP. A THIRD ROUND OF HYLENEX WAS INJECTED VIA NEEDLE AND CANNULA TO FLOOD THE ENTIRE UPPER LIP AREA AND WAS AGAIN FOLLOWED WITH WARM COMPRESSES AND MASSAGE. AFTER THE THIRD ROUND OF HYLENEX, THE PATIENT SHOWED IMPROVEMENT. THE DUSKY APPEARANCE RESOLVED AND LEFT A SLIGHTLY ROSY BLUSHED AREA. CAPILLARY REFILL RETURNED TO NORMAL PER THE HCP. NO OTHER ISSUES WERE NOTED AT ANY OTHER INJECTION SITE. THE PATIENT WAS MONITORED FOR APPROXIMATELY 3 HOURS IN THE OFFICE DURING THIS PROCESS AND THEN RELEASED TO GO HOME. HYLENEX, A TOTAL OF 850 UNITS INJECTED OVER 3 TREATMENTS. ON (B)(6) 2020, THE PATIENT WAS SEEN IN THE OFFICE AGAIN AND THE UPPER LIP WAS NOTED TO HAVE A DARKER DUSKY APPEARANCE AGAIN, MORE TO THE LEFT SIDE THAN THE RIGHT. THE PATIENT ALSO REPORTED SHARP PAIN/STINGING(IMPLANT SITE PAIN) AROUND THE CUPID'S BOW AREA OF THE UPPER LIP. THE HCP INJECTED ANOTHER ROUND OF HYLENEX TO THE UPPER LIP AND FOLLOWED WITH WARM COMPRESSES AND MASSAGE. A TOTAL OF 650 UNITS OF HYLENEX WAS INJECTED DURING THE FOLLOW UP SESSION. THE COLOR RETURNED TO A NORMAL BLUSH COLOR ALONG THE UPPER LIP, GOOD CAPILLARY REFILL REPORTED. THE PAIN RESOLVED AND NORMAL SENSATION WAS REPORTED. THE PATIENT WAS MONITORED FOR APPROXIMATELY 1 HOUR IN THE CLINIC. ON (B)(6) 2020, THE PATIENT WAS RECHECKED AGAIN IN THE CLINIC. THE PATIENT REPORTED MILD STINGING TO THE LEFT UPPER LIP. THE COLOR REMAINED NORMAL AND CAPILLARY REFILL REMAINED NORMAL AS WELL. NO PAIN, NO SWELLING OR ASYMMETRY NOTED. NO FURTHER TREATMENT GIVEN AT THIS TIME. ON (B)(6) 2020, THE PATENT WAS FOLLOWED UP VIA PHONE AND FACE TIME WITH THE INJECTOR. THE PATIENT REPORTED STILL MILD STINGING PERSISTED IN THE UPPER LIP TO THE LEFT SIDE BUT THE COLOR REMAINED PINK AND GOOD CAPILLARY REFILL WAS REPORTED. THE PATIENT HAS A FOLLOW UP APPOINTMENT WITH THE HCP ON (B)(6) 2020. OUTCOME AT THE TIME OF THE REPORT: VASCULAR OCCLUSION WAS RECOVERED/RESOLVED. FAINT RED LACY DISCOLORATION/SLIGHTLY DUSKY IN APPEARANCE WAS RECOVERED/RESOLVED. SWELLING WAS RECOVERED/RESOLVED. SLUGGISH CAPILLARY REFILL WAS RECOVERED/RESOLVED. SHARP PAIN/STINGING WAS NOT RECOVERED/NOT RESOLVED." }, { "mdr_text_key": "318102742", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2020 BY AN OTHER HEALTH PROFESSIONAL WHICH REFERS TO A 63-YEAR-OLD FEMALE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020 FROM SAME REPORTER. THE PATIENT HAD FITZPATRICK SKIN TYPE III-IV. DENIED ANY MEDICAL HISTORY. THE PATIENT NO ALLERGIES. CONCOMITANT TREATMENTS INCLUDED DYSPORT [DYSPORT] AND VITAMIN D [VITAMIN D NOS]. THE PATIENT HAD PREVIOUSLY RECEIVED TREATMENT WITH RESTYLANE REFYNE TO LIPS ON (B)(6) 2019 AND RESTYLANE-L TO ORAL COMMISSURES ON (B)(6) 2019. ON (B)(6) 2020, THE PATIENT RECEIVED TREATMENT WITH 9 ML RESTYLANE-L (LOT 16999) TO LIPS (0.1 ML PER SIDE), ORAL COMMISSURE (0.15 ML PER SIDE) WITH JULIE HORN TECHNIQUE AND TO MENTOLABIAL FOLDS (0.15 ML RIGHT, 0.25 ML LEFT SIDE) WITH FAN TECHNIQUE USING 29 G AND 31 G NEEDLE. ON THE SAME DAY, PATIENT ALSO RECEIVED TREATMENT WITH 1 ML RESTYLANE DEFYNE (LOT 17524) TO POSTERIOR JAW (0.2 ML PER SIDE), NASOLABIAL FOLDS (0.15 ML PER SIDE), CHIN (0.3 ML) USING 27G HALF NEEDLE, DEEP INTO PERIOSTEUM AND 1 ML RESTYLANE LYFT WITH LIDOCAINE (LOT 17082) TO CHEEKS, MIDFACE, TEAR TROUGH (0.4 ML RIGHT AND 0.6 ML LEFT SIDE) USING 29G NEEDLE DOWN TO BONY PERIOSTEUM. ALSO INJECTED WITH DYSPORT [DYSPORT] TO 20 UNITS TO GLABELLA, 20 UNITS TO CROW'S FEET, 10 UNITS TO FOREHEAD, AND 5 UNITS TO NASALIS, IN TOTAL 55 UNITS. PATIENT WAS INJECTED WITH RESTYLANE LYFT AND PROGRESSED TO THE RESTYLANE DEFYNE INJECTION. THE HCP REPORTED THAT SHE THEN INJECTED THE RESTYLANE-L TO THE LIPS STARTING WITH THE UPPER LIP, RIGHT SIDE AND PROGRESSING THE UPPER LEFT LIP AND THEN ON TO THE LOWER LIP. ON (B)(6) 2020, AFTER THE LIP INJECTION COMPLETED, THE HCP NOTED A FAINT RED LACY DISCOLORATION/SLIGHTLY DUSKY IN APPREARANCE(IMPLANT SITE DISCOLOURATION) TO THE RIGHT UPPER LIP AS WELL AS A MILD ASYMMETRIC SWELLING(IMPLANT SITE SWELLING) TO THE RIGHT SIDE OF THE UPPER LIP. THE HCP THEN WENT TO INJECT DYSPORT IN THE FOREHEAD, GLABELLA AND CROW'S FEET AREAS. AFTER COMPLETING THE DYSPORT INJECTION, HCP RE-ASSESSED THE LIP AREA AND NOTED THE ASYMMETRY PERSISTED AND THE RED LACY DISCOLORATION APPEARED TO BECOME SLIGHTLY DUSKY IN APPREARANCE AND HAD PROGRESSED TO INCLUDE SOME OF THE UPPER LEFT LIP. SLUGGISH CAPILLARY REFILL(POOR PERIPHERAL CIRCULATION) WAS NOTED. IT WAS REPORTED THAT PATIENT EXPERIENCED A VASCULAR OCCLUSION(VASCULAR OCCLUSION) FROM RESTYLANE-L INJECTED IN THE LIPS AND ORAL COMMISURE. AT THIS POINT THE HCP ELECTED TO INJECT WITH HYLENEX [HYALURONIDASE] MIXED WITH 2% LIDOCAINE [LIDOCAINE], APPROXIMATELY 300 UNITS, TO THE UPPER LIP AREA. A TOTAL OF 5 ML OF WAS INJECTED. THE HCP FOLLOWED THE INJECTION OF HYLENEX WITH WARM COMPRESSES AND VIGOROUS MASSAGE. AFTER 15 MINUTES, THE HCP RE-CHECKED THE AREA AND DID NOT FEEL THERE WAS IMPROVEMENT. THE HYLENEX WAS REPEATED AS WELL AS THE WARM COMPRESSES AND MASSAGE. AFTER ANOTHER 15 MINUTES, THE PATIENT STILL HAD A DUSKY APPEARANCE TO THE UPPER LIP. A THIRD ROUND OF HYLENEX WAS INJECTED VIA NEEDLE AND CANNULA TO FLOOD THE ENTIRE UPPER LIP AREA AND WAS AGAIN FOLLOWED WITH WARM COMPRESSES AND MASSAGE. AFTER THE THIRD ROUND OF HYLENEX, THE PATIENT SHOWED IMPROVEMENT. THE DUSKY APPEARANCE RESOLVED AND LEFT A SLIGHTLY ROSY BLUSHED AREA. CAPILLARY REFILL RETURNED TO NORMAL PER THE HCP. NO OTHER ISSUES WERE NOTED AT ANY OTHER INJECTION SITE. THE PATIENT WAS MONITORED FOR APPROXIMATELY 3 HOURS IN THE OFFICE DURING THIS PROCESS AND THEN RELEASED TO GO HOME. ON (B)(6) 2020, THE PATIENT WAS SEEN IN THE OFFICE AGAIN AND THE UPPER LIP WAS NOTED TO HAVE A DARKER DUSKY APPEARANCE AGAIN, MORE TO THE LEFT SIDE THAN THE RIGHT. THE PATIENT ALSO REPORTED SHARP PAIN/STINGING/TENDERNESS(IMPLANT SITE PAIN) AROUND THE CUPID'S BOW AREA OF THE UPPER LIP. THE HCP INJECTED ANOTHER ROUND OF HYLENEX, 3.5 ML TO THE UPPER LIP AND FOLLOWED WITH WARM COMPRESSES AND MASSAGE. A TOTAL OF 650 UNITS OF HYLENEX WAS INJECTED DURING THE FOLLOW UP SESSION. THE COLOR RETURNED TO A NORMAL BLUSH COLOR ALONG THE UPPER LIP, GOOD CAPILLARY REFILL REPORTED. THE PAIN RESOLVED AND NORMAL SENSATION WAS REPORTED. THE PATIENT WAS MONITORED FOR APPROXIMATELY 1 HOUR IN THE CLINIC. ON (B)(6) 2020, THE PATIENT WAS RECHECKED AGAIN IN THE CLINIC. THE PATIENT REPORTED MILD STINGING TO THE LEFT UPPER LIP. THE COLOR REMAINED NORMAL AND CAPILLARY REFILL REMAINED NORMAL AS WELL. NO PAIN, NO SWELLING OR ASYMMETRY NOTED. NO FURTHER TREATMENT GIVEN AT THIS TIME. ON (B)(6) 2020, THE PATENT WAS FOLLOWED UP VIA PHONE AND FACE TIME WITH THE INJECTOR. THE PATIENT REPORTED STILL MILD STINGING PERSISTED IN THE UPPER LIP TO THE LEFT SIDE BUT THE COLOR REMAINED PINK AND GOOD CAPILLARY REFILL WAS REPORTED. THE PATIENT HAS A FOLLOW UP APPOINTMENT WITH THE HCP ON (B)(6) 2020. UNKNOWN TIME LATER, ON AN UNKNOWN DATE IN 2020, THE PATIENT HAD SLIGHT REDNESS(IMPLANT SITE ERYTHEMA) AND TENDERNESS OF LEFT UPPER LIP, BUT IMPROVING DAILY. OUTCOME AT THE TIME OF THE REPORT: VASCULAR OCCLUSION WAS RECOVERED/RESOLVED WITH SEQUELAE. FAINT RED LACY DISCOLORATION/SLIGHTLY DUSKY IN APPREARANCE WAS RECOVERED/RESOLVED. SWELLING WAS RECOVERED/RESOLVED. SLUGGISH CAPILLARY REFILL WAS RECOVERED/RESOLVED. SHARP PAIN/STINGING/TENDERNESS WAS RECOVERING/RESOLVING. REDNESS WAS RECOVERING/RESOLVING. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON 02-JUN-2020 FROM SAME REPORTER: EVENT (REDNESS) ADDED. EVENT VERBATIM OF IMPLANT SITE PAIN UPDATED. PATIENT DEMOGRAPHICS, PAST FILLER TREATMENTS, SUSPECT AND CONCOMITANT DEVICE, VOLUME, NEEDLE TYPE, INJECTION TECHNIQUE, LOCATION, LOT NUMBER, LOCATION, OUTCOME, SEVERITY AND REPORTER CAUSALITY FOR EVENT VASCULAR OCCLUSION WERE UPDATED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/15/2020" } ] }