BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR/COLOPLAST

    MDR report key: 1970008 · Received January 19, 2011

    Report

    Report Number
    MW5019086
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 10, 2011
    Manufacturer
    UNK
    Product Code
    FAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT'S HISTORY UNAVAILABLE. WAS BROUGHT TO OPERATING ROOM ON (B)(6), FOR REVISION OF "MALFUNCTIONING" PENILE PROSTHESIS, PER MD NOTES. THE OPERATIVE NOTE INDICATES THAT THERE WAS A FAILURE OF "ONE OF THE TUBES" AND A "RESERVOIR" FAILURE, OR "HOLE" IN RESERVOIR. IDENTIFICATION AND NUMBERS ON THE EXPLANTED DEVICE WERE AS FOLLOWS: MENTOR COMPANION 60CC, (B)(4) AND (B)(4) (RETRIEVED FROM IMPLANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR/COLOPLAST PENILE IMPLANT FAE UNK 28830 128920

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR