BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2573653 · Received April 13, 2012

    Report

    Report Number
    2573653
    Event Type
    Malfunction
    Date Received
    April 13, 2012
    Date of Event
    March 27, 2012
    Report Date
    April 13, 2012
    Manufacturer
    COLOPLAST CORP
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER THE OPERATIVE REPORT, THE PATIENT HAS HAD AN INFLATABLE PENILE IMPLANT THAT HAS BEEN WORKING WELL UNTIL VERY RECENTLY WHEN IT TOTALLY STOPPED INFLATING. I TESTED IT AND IT DID NOT INFLATE AT ALL. AN X-RAY SHOWED THAT THE RESERVOIR APPEARED TO BE EMPTY. ARRANGEMENTS WERE MADE TO RETURN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BIOFLEX RESERVOIR FHW COLOPLAST CORP * 771079
    2 * INFRAPUBIC CYLINDER WITH PUMP FHW COLOPLAST CORP * 0906876
    3 * TITAN ASSEMBLY KIT FHW COLOPLAST CORP * 799103

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR