BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEYER-SCHULTE

    MDR report key: 549784 · Received July 22, 2004

    Report

    Report Number
    MW1032837
    Event Type
    Injury
    Date Received
    July 22, 2004
    Report Date
    July 21, 2004
    Manufacturer
    HEYER-SCHULTE CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1983 PT AUGMENTED WITH HEYER-SCHULTE SALINE/GEL IMPLANTS. IN 2001 MAMMOGRAM=POSSIBLE RUPTURE RIGHT SIDE. IN 2004 PT UNDERWENT BILATERAL CAPSULECTOMY WITH REMOVAL OF RUPTURED GEL IMPLANTS. PT AUGMENTED WITH MENTOR GEL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE MAMMARY IMPLANTS SILICONE/SALINE FTR HEYER-SCHULTE CORP. 5000 ROUND TOTAL VOLUME 250CC 226677

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention