BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLOPLAST ALPHA 1

    MDR report key: 2993124 · Received February 26, 2013

    Report

    Report Number
    MW5029198
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    August 30, 2012
    Report Date
    February 26, 2013
    Manufacturer
    COLOPLAST
    Product Code
    FHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PENILE IMPLANT WAS MANUFACTURED BY COLOPLAST CORP (B)(4) MODEL ALPHA 1, TITAN IS THE NAME OF THE RESERVOIR AND IT USES AN OTR PUMP. (B)(6). THE IMPLANT CONSISTS OF A RESERVOIR WHICH IS PLACED IN THE ABDOMEN, PUMP AND RELEASE VALVE THAT IS PLACED IN THE SCROTUM AND TWO TUBES THAT ARE PLACED LENGTH-WISE IN THE SHAFT OF THE PENIS. THIS DEVICE WAS IMPLANTED INTO ME ON (B)(6) 2012. IT WAS REMOVED ON (B)(6) AND ANOTHER WAS IMPLANTED AT THAT TIME. EACH ONE FAILED AND HAD TO BE REMOVED. REASON FOR USE: WOULD NOT DEFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81025 COLOPLAST ALPHA 1 PENILE IMPLANT FHW COLOPLAST ALPHA 1
    81026 COLOPLAST ALPHA 1 PENILE IMPLANT FHW COLOPLAST ALPHA 1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Congenital Anomaly