BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEYER-SCHULTE CORPORATION

    MDR report key: 201937 · Received November 25, 1998

    Report

    Report Number
    201937
    Event Type
    Malfunction
    Date Received
    November 25, 1998
    Date of Event
    November 25, 1998
    Report Date
    November 25, 1998
    Manufacturer
    HEYER-SCHULTE CORP.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANTS REMOVED; BOTH IMPLANTS RUPTURED. PT HAS REQUESTED HER IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE CORPORATION Implant RIGHT AND LEFT BREAST IMPLANTS 400CC FWM HEYER-SCHULTE CORP. STYLE 7000 228896

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other HEYER-SCHULTE CORP.