BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN

    MDR report key: 11098589 · Received December 30, 2020

    Report

    Report Number
    2125050-2020-01350
    Event Type
    Injury
    Date Received
    December 30, 2020
    Report Date
    October 26, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932487368
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A TITAN PUMP, AND CYLINDERS 1 AND 2 WERE RECEIVED FOR EVALUATION. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. TWO SEPARATIONS WERE NOTED IN THE BLADDER OF CYLINDER 1. THESE WERE BOTH SITES OF LEAKAGE. BOTH SEPARATIONS HAD A CENTRAL GROOVE, INDICATING CONTACT WITH SHARP INSTRUMENTATION SUCH AS A NEEDLE. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDER 2. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, IT WAS CONCLUDED THAT THE OBSERVED INSTRUMENT SEPARATIONS IN THE BLADDER OF CYLINDER 1 OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. DUE TO THE BRIEF PERIOD OF TIME IN-VIVO, AND AS THE TWO SEPARATIONS APPEAR NEAR EACH OTHER, QUALITY CONCLUDED THAT THE SEPARATIONS NOTED MOST LIKELY WERE DUE TO NEEDLE STICKS WHICH MAY HAVE INADVERTENTLY OCCURRED DURING THE CLOSURE AT IMPLANT. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT. D4 LOT# 7050987.

    Additional Manufacturer Narrative · 1

    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. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, LEAK WAS DISCOVERED IN LEFT CYLINDER. THE DEVICE WAS REVISED/REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558788 TITAN INFLATABLE PENILE PROTHESIS FHW COLOPLAST A/S ES89202400 05708932487368

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention