BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS, INC.

    MDR report key: 346269 · Received August 8, 2001

    Report

    Report Number
    2183959-2001-00022
    Event Type
    Injury
    Date Received
    August 8, 2001
    Date of Event
    July 10, 2001
    Report Date
    August 8, 2001
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1992, THIS PATIENT WAS ORIGINALLY IMPLANTED WITH AN IPP DEVICE. INFORMATION RECEIVED ON 7-11-01, INDICATES ON EVENT DATE, THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED DUE TO FLUID LOSS; ON THE PREVIOUS CYLINDERS THE OUTER SHEATH OF BOTH CYLINDERS HAD SPLIT OPEN AND COMPLETELY GROWN IN THE CORPORA. AFTER THE CYLINDERS WERE REMOVED FROM THE PATIENT IT LEFT A 4 TO 5CM GAP THAT LITERALLY LOOKED LIKE "SWISS CHEESE," IN THE CORPORA ON BOTH SIDES. THE DOCTOR USED GORTEX TUBE GRAFT TO COVER NEW CYLINDERS IN THE CORPORA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35900 AMERICAN MEDICAL SYSTEMS, INC. IPP FHW AMERICAN MEDICAL SYSTEMS, INC. IPP 7218P 015, 6773P 001

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R