{ "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": 111 } }, "results": [ { "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": "1226486-2020-00001", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200624", "manufacturer_address_2": "", "pma_pmn_number": "K151473", "date_of_event": "20200228", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "USER FACILITY" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200624", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "655611", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200624", "brand_name": "PIQO4", "generic_name": "POWERED LASER SURGICAL INSTRUMENT", "manufacturer_d_name": "FOCUS MEDICAL", "manufacturer_d_address_1": "23 FRANCIS J. CLARKE CIRCLE", "manufacturer_d_address_2": "", "manufacturer_d_city": "BETHEL, CT", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "PIQO4", "catalog_number": "GA-4000001", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200622", "device_report_product_code": "GEX", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Powered Laser Surgical Instrument", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4810", "device_class": "2" } } ], "product_problems": [ "Output below Specifications", "Output below Specifications" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20200624", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20200624", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10192416", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200309", "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": "201060161", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "REASONABLE ATTEMPTS BY PHONE (3X) AND EMAIL (3X) WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY PHYSICIAN INCLUDING PATIENT INFORMATION, TREATMENT SETTINGS AND PHOTOGRAPHS, HOWEVER ONLY PATIENT PHOTOS WERE RECEIVED; THEREFORE, FOCUS MEDICAL IS UNABLE TO EVALUATE THE TREATMENT PARAMETERS TO DETERMINE THEIR APPROPRIATENESS FOR TREATMENT. AN EXAMINATION OF THE SUBJECT DEVICE BY A TRAINED TECHNICAL EXPERT CONCLUDED THAT THE SUBJECT DEVICE WAS DELIVERING LOWER THAN NORMAL OUTPUT ENERGY. FOLLOWING REPLACEMENT OF THE OSCILLATOR AND PICKER BOARD, THE TECHNICAL EXPERT WAS STILL UNABLE TO OBTAIN MANUFACTURE SPECIFICATIONS. THE SUBJECT DEVICE WAS REMOVED FROM THE USER FACILITY AND RETURNED BACK TO THE MANUFACTURER FOR FURTHER ANALYSIS. A MEDICAL PROFESSIONAL REVIEWED THE PATIENT PHOTOGRAPHS, WHICH WERE TWO WEEKS POST TREATMENT AND CONCLUDED THAT THE EVENT APPEARS TO BE A POST PROCEDURE INFECTION. MINUS PATIENT INFORMATION AND TREATMENT SETTINGS, THE MEDICAL PROFESSIONAL IS UNABLE TO CONDUCT A FULL CLINICAL REVIEW. WHILE THE INFORMATION RECEIVED TO DATE DOES NOT CONFIRM THAT A SERIOUS INJURY OCCURRED AND/OR MEDICAL INTERVENTION OR MEDICATION WAS PRESCRIBED, THE COMPANY IS REPORTING THE EVENT IN AN ABUNDANCE OF CAUTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED. A REVIEW OF THE SUBJECT DEVICE DHR CONFIRMED THAT THE SUBJECT DEVICE WAS MANUFACTURED AND TESTED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, AND SHIPPED ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS. MANUFACTURE DATE: JUNE 19, 2019 DUE TO COVID-19 AND COMPANY SHUTDOWN, THIS MDR IS BEING SUBMITTED UNDER THE GUIDANCE FOR INDUSTRY - POSTMARKETING ADVERSE EVENT REPORTING FOR MEDICAL PRODUCTS AND DIETARY SUPPLEMENTS DURING A PANDEMIC." }, { "mdr_text_key": "201060162", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A SMALL BURN ON AN UNKNOWN ANATOMICAL AREA FOLLOWING TATTOO REMOVAL TREATMENT WITH A FOCUS MEDICAL PIQO4 LASER, ZOOM HANDPIECE. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION WAS RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY." } ], "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": "" } ] }