BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEYER SCHULTE

    MDR report key: 167989 · Received May 13, 1998

    Report

    Report Number
    167989
    Event Type
    Injury
    Date Received
    May 13, 1998
    Date of Event
    May 5, 1998
    Report Date
    May 12, 1998
    Manufacturer
    HEYER SCHULTE CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BILATERAL SILICONE IMPLANTS IN 1977 FOR FIBROCYSTIC DISEASE. CHANGE OF SIZE NOTED. BILATERAL SILICONE IMPLANTS RUPTURED. REMOVED 5/8/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER SCHULTE Implant BREAST IMPLANT-SILICONE FTR HEYER SCHULTE CORP. STYLE 2100 LT R133863
    2 HEYER SCHULTE Implant BREAST IMPLANT-SILICONE FTR HEYER SCHULTE CORP. STYLE 2100 RT 143064

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention