BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN RES ECLD 75CC

    MDR report key: 8021402 · Received October 30, 2018

    Report

    Report Number
    2125050-2018-00784
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 1, 2018
    Report Date
    November 21, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932473910
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A RESERVOIR WAS RECEIVED FOR EVALUATION. QUALITY SEVERED THE RESERVOIR INLET TUBING TO CONDUCT FUNCTIONAL TESTING. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED NO VISUAL OR FUNCTIONAL ABNORMALITIES WITH THE RESERVOIR OR THE DETACHED TUBING/CONNECTOR. THE INFORMATION RECEIVED INDICATED "POSSIBLE AUTO-INFLATION," BUT BECAUSE NO VISUAL OR FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS, QUALITY CANNOT CONFIRM THE COMPLAINT AS REPORTED. QUALITY REVIEWED THE MANUFACTURING RECORDS FOR THIS DEVICE AND CONFIRMED THAT THERE WERE NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT AND VERIFIED THAT THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF THE COMPLAINT DATABASE REVEALED NO SIGNIFICANT TRENDS IN COMPLAINTS OF THIS TYPE FOR LOT 6121935.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT COLOPLAST; HOWEVER THE EVALUATION IS NOT YET COMPLETE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, AUTO INFLATION, MOVED TO THE RESERVOIR TO THE ECTOPIC PLACEMENT AND IMPLANTED A 125 CC RESERVOIR. FIXED THE ISSUE OF AUTO-INFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858588 TITAN RES ECLD 75CC INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ER80752400 6121935 05708932473910

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other