BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS 3 PIECE PENILE IMPLANT

    MDR report key: 12066695 · Received June 24, 2021

    Report

    Report Number
    MW5102139
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVICE STOPPED WORKING AND ONLY ACTION WILL BE SURGERY TO REMOVE AND REPLACE. WHICH WILL COST MONEY I DON'T HAVE IN ADDITION TO PAIN, SUFFERING, MENTAL DEPRESSION, AND HUMILIATION. IT'S A PENILE IMPLANT DEVICE THAT DON'T WORK ANYMORE AND NEEDS SURGERY TO CORRECT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954208 AMS 3 PIECE PENILE IMPLANT PROSTHESIS, PENIS, INFLATABLE JCW BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other