BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEYER-SCHULTE

    MDR report key: 64703 · Received December 26, 1996

    Report

    Report Number
    64703
    Event Type
    Injury
    Date Received
    December 26, 1996
    Date of Event
    November 26, 1996
    Report Date
    December 4, 1996
    Manufacturer
    HEYER-SCHULTE CORP. SUB OF AMERICAN HOSPITAL SUPPLY CORP.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF ONSET OF DIABETES, CHRONIC FATIGUE, MUSCLE ACHES AND JOINT ARTHRALGIAS FOR PAST 1 1/2 TO 2 YEARS. FELT THAT BREAST IMPLANTS WERE RUPTURED. SURGERY TO REMOVE IMPLANTS CONFIRMED THIS. THE MEDICAL DEVICES CANNOT BE RULED OUT AS A POSSIBLE CAUSE OF PT'S COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE Implant BREAST PROSTHESIS FWM HEYER-SCHULTE CORP. SUB OF AMERICAN HOSPITAL SUPPLY CORP. * 5073560

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization