BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEYER-SCHULTE

    MDR report key: 215720 · Received March 22, 1999

    Report

    Report Number
    MW1015959
    Event Type
    Malfunction
    Date Received
    March 22, 1999
    Date of Event
    January 11, 1999
    Report Date
    March 9, 1999
    Manufacturer
    HEYER-SCHULTE CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT "HAS HAD HEYER-SCHULTE SILICONE GEL IMPLANTS." EXAM SUGGESTED SIGNIFICANT CAPSULAR CONTRACTURE. RADIOGRAPHS DOCUMENTED A LEFT IMPLANT RUPTURE. DURING SURGERY, IT WAS DISCOVERED THE RIGHT BREAST WAS RUPTURED AS WELL, REQUIRING BILATERAL EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE Implant SILICONE GEL BREAST IMPLANTS FTR HEYER-SCHULTE CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other