BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYER SCHULTE BREAST IMPLANTS

    MDR report key: 15528 · Received July 21, 1994

    Report

    Report Number
    15528
    Event Type
    Injury
    Date Received
    July 21, 1994
    Date of Event
    March 10, 1994
    Report Date
    April 11, 1994
    Manufacturer
    HEYER SCHULTE CORP, SUBSIDARY
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    3/10/1994 REMOVAL MADE OF BILAT BREAST IMPLANTS - REPLACED WITH SALINE, RIGHT IMPLANT LEAKED, LEFT IMPLANT NO EVIDENCE OF LEAK. SILICON GRANULOMAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYER SCHULTE BREAST IMPLANTS Implant BREAST IMPLANTS FTR HEYER SCHULTE CORP, SUBSIDARY 7000 210619

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability