BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS, INC.

    MDR report key: 87027 · Received April 23, 1997

    Report

    Report Number
    2126328-1997-01685
    Event Type
    Injury
    Date Received
    April 23, 1997
    Date of Event
    March 25, 1997
    Report Date
    April 23, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    ON 1/22/93 AN IPP DEVICE WAS IMPLANTED. ON 3/24/97 IT WAS REPORTED THAT THE PT HAS A DEVICE "WHICH IS APPARENTLY MALFUNCTIONING." "NO SPECIFICS WERE PROVIDED AS TO THE TYPE OF MALFUNCTION WHICH MAY HAVE OCCURRED, HAS CO BEEN PROVIDED WITH INFO THAT WOULD INDICATE IT WAS REMOVED OR REPLACED." ADD'L LOT/SER NO: 2853Q 002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS, INC. Implant AMERMEDISYST FHW AMERICAN MEDICAL SYSTEMS, INC. 700 4110L 003,4110L 003,3006Q 002

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability