{
  "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": {
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    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "report_to_fda": "*",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "3005113652-2020-00222",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20200427",
      "manufacturer_address_2": "",
      "pma_pmn_number": "P110033",
      "date_of_event": "20200315",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "NURSE",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
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      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20200427",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "464536",
          "implant_date_year": "2019",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200427",
          "brand_name": "JUVEDERM VOLLURE XC 2X1 ML",
          "generic_name": "IMPLANT, DERMAL, FOR AESTHETIC USE",
          "manufacturer_d_name": "ALLERGAN (PRINGY)",
          "manufacturer_d_address_1": "ROUTE DE PROMERY",
          "manufacturer_d_address_2": "ZONE ARTISANALE DE PRE-MAIRY",
          "manufacturer_d_city": "PRINGY",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "74370",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "FR",
          "manufacturer_d_postal_code": "74370",
          "device_operator": "HEALTH PROFESSIONAL",
          "expiration_date_of_device": "20201025",
          "model_number": "",
          "catalog_number": "95661",
          "lot_number": "V17LA80824",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "LMH",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "Y",
          "udi_di": "10888628034471",
          "udi_public": "10888628034471",
          "openfda": {
            "registration_number": [
              "3005113652"
            ],
            "fei_number": [
              "3005113652"
            ],
            "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": "CO",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250807",
      "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": "20200427",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "51 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Unspecified Infection",
            "Inflammation",
            "Skin Irritation",
            "Unspecified Infection",
            "Inflammation",
            "Skin Irritation"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200427",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10001634",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200331",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer 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": "190492563",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING."
        },
        {
          "mdr_text_key": "190492564",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED IN THE ORAL COMMISSURES AND THE PERIORAL AREA WITH ONE SYRINGE OF JUVÉDERM VOLLURE¿ XC. ABOUT THREE MONTHS LATER, THE PATIENT EXPERIENCED ¿SWELLING BELOW THE ORAL COMMISSURES, HARD NODULES ABOVE THE UPPER LIP\", AND REDNESS AROUND THE NODULES. PATIENT WAS TREATED WITH HYALURONIDASE 150, ON ALL NODULES AND A MEDROL DOSE PACK. INJECTOR NOTED THIS IS A DELAYED INFLAMMATORY REACTION AND A POSSIBLE BIOFILM. THREE DAYS LATER, THE SYMPTOMS IMPROVED BUT NODULES STILL PRESENT."
        }
      ],
      "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": ""
    }
  ]
}