BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS, INC.

    MDR report key: 99932 · Received June 20, 1997

    Report

    Report Number
    99932
    Event Type
    Injury
    Date Received
    June 20, 1997
    Date of Event
    May 27, 1997
    Report Date
    June 20, 1997
    Manufacturer
    AMERICAN MEDICAL SYS, INC. PFIZER HOSP PROD GROUP
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROSTHESIS NO LONGER FUNCTIONAL - STOPPED WORKING - REMOVED & REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS, INC. Implant PENILE PROSTHESIS - INFLATABLE FHW AMERICAN MEDICAL SYS, INC. PFIZER HOSP PROD GROUP * *
    2 1 FHW

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O AMS QUICK CONNECT 72400270/37393P - 028| PRODUCT # 72400001/6482P-027| AMS 1PP PREP PKG 101/SER| AMS UT RES 65ML 72401476/2956P - 012| AMS UT 18 CM 72401467/9862M003