BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL BREAST IMPLANT

    MDR report key: 6953 · Received October 14, 1993

    Report

    Report Number
    6953
    Event Type
    Injury
    Date Received
    October 14, 1993
    Date of Event
    October 1, 1993
    Report Date
    October 14, 1993
    Manufacturer
    N/A
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    CAPSULAR FORMATION ON BOTH BREAST. CAPSULOTOMY PERFORMED ON BOTH BREASTS WITH EXCHANGE FROM GEL IMPLANTS TO SALINE IMPLANTS.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL BREAST IMPLANT Implant FTR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention