BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 8577979 · Received May 3, 2019

    Report

    Report Number
    9710154-2019-00026
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    October 24, 2016
    Report Date
    May 3, 2019
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P030050/S2
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: LOT NUMBER WAS NOT REPORTED. PHARMACOVIGILANCE COMMENT: THE SERIOUS EVENT OF UNILATERAL BLINDNESS WAS CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDE PERMANENT DAMAGE. POTENTIAL CONTRIBUTORY FACTORS INCLUDE INJECTION TECHNIQUE. 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. EXEMPTION: GALDERMA LABORATORIES L.P. IS SUBMITTING THIS REPORT ON BEHALF OF Q-MED AB. EXEMPTION NUMBER E2015005

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 25-APR-2019. THE CASE CONCERNS A FEMALE PATIENT OF UNKNOWN AGE. THIS CASE WAS RECEIVED BY TV NEWS REPORTING. NO INFORMATION ABOUT MEDICAL HISTORY, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6) 2016, THE PATIENT RECEIVED TREATMENT WITH SCULPTRA TO FOREHEAD (UNKNOWN AMOUNT, LOT NUMBER, INJECTION TECHNIQUE AND NEEDLE TYPE). IMMEDIATELY AFTER INJECTION ON (B)(6) 2016, THE PATIENT EXPERIENCED RIGHT EYE VISUAL LOSS (BLINDNESS UNILATERAL). IT WAS REPORTED THAT THE PATIENT RECEIVED INJECTION BY A LOCAL NURSE WORKING AT AN UNKNOWN CLINIC. THE PATIENT ACCUSED THE NURSE FOR THE INJECTION AND COURT JUDGED CRIMINAL RESPONSIBILITY WAS CONFIRMED AND TV NEWS REPORTED THIS EVENT IN PUBLIC. THEN THE COMPANY BECAME AWARE OF THIS CASE. TREATMENT FOR THE ADVERSE EVENT WAS NOT REPORTED. THE CAUSALITY WAS REPORTED AS POSSIBLE. OUTCOME AT THE TIME OF THE REPORT: VISUAL LOSS WAS NOT RECOVERED/NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370701 SCULPTRA IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability