BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 12086432 · Received June 28, 2021

    Report

    Report Number
    MW5102182
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 24, 2021
    Manufacturer
    AMS / BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AMS BRAND 3-PIECE PENOSCROTAL INFLATABLE PENILE PROSTHESIS DUE TO PRODUCT MALFUNCTION. UNKNOWN ABOUT SERIAL NUMBER OR LOT NUMBER DUE TO DEVICE BEING PLACED AT ANOTHER LOCATION, REPORTEDLY IN (B)(6) 2017. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978033 INFLATABLE PENILE PROSTHESIS PROSTHESIS, PENIS, INFLATABLE JCW AMS / BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR