BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENILE INSERTION DEVICE

    MDR report key: 6072149 · Received October 31, 2016

    Report

    Report Number
    MW5065745
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    January 1, 2011
    Report Date
    October 31, 2016
    Manufacturer
    AMA - COLOPLAST CORP.
    Product Code
    LKY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT HIS DEVICE MALFUNCTIONED AND IS CAUSING HIM A LOT OF PAIN. REPORTER STATES THAT HE IS RUNNING OUT OF MONEY AND UNABLE TO GET THE DEVICE EXPLANTED SINCE HE HAS HAD TO PAY FOR THIS DEVICE THREE TIMES. HE HAS BEEN, AND IS STILL IN PAIN AND VERY FRUSTRATED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717955 PENILE INSERTION DEVICE PENILE INSERTION DEVICE LKY AMA - COLOPLAST CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR