BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEYER-SCHULTE

    MDR report key: 292261 · Received August 22, 2000

    Report

    Report Number
    MW1019739
    Event Type
    Injury
    Date Received
    August 22, 2000
    Date of Event
    November 23, 1999
    Report Date
    July 19, 2000
    Manufacturer
    HEYER-SCHULTE
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "S/P B SQ MASTX'S FOR FCD, PRIOR BX'S (ASP, - FH). HAD B SUBPECTORAL H/S 210:140 BILUMENS. THE R BECAME ENCAPSULATED AND HAD TO HAVE A R OPEN CAPSULOTOMY AND EXCISION OF B FIBRO-FATTY BREAST TISSUE IN THE IMF'S. APPTLY PT DEVELOPED CHRONIC ABSCESSES IN R S/P THAT SX SO IN 1977 HAD EXPLORATION WITH CULTURES/PACKING AND A L CLOSED CAPSULOTOMY. APPTLY THIS WAS UNSUCCESSFUL AND THE IMPLANT WAS REMOVED (NO RECORDS). PRESENTED FOR R SALINE REPLACEMENT. L WAS ALSO REPLACED WTIH SALINES (325CC H/S) SECONDARY TO CONTRACTURE. DEVELOPED A R HEMATOMA WHICH HAD TO BE EVACUATED. POST-OP THE R HAS NEVER BEEN CORRECT WITH RIPPLING AND DEEP PAIN. HAS LIVED WITH IT HOWEVER UNTIL 1999 WHEN THE L DEFLATED. PRESENTS NOW DESIRING TRAM FLAP RECONSTRUCTION. PT HAS HAD SYSTEMIC C/O'S, SOME OF WHICH PREDATED IMPLANTS. PT IS OTHERWISE HEALTHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE GEL BREAST IMPLANTS FTR HEYER-SCHULTE NA R160786

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| S