BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN

    MDR report key: 11033384 · Received December 17, 2020

    Report

    Report Number
    2125050-2020-01311
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 4, 2020
    Report Date
    July 7, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A TITAN OTR PUMP AND TWO CYLINDERS WERE RECEIVED FOR ANALYSIS. A SEPARATION WITHIN ABRASION WAS NOTED ON ONE OF EXHAUST TUBES OF THE PUMP AT THE TUBE/STRAIN RELIEF JUNCTION. THIS WAS A SITE OF LEAKAGE. ABRASION WAS ALSO NOTED ON THE OTHER EXHAUST TUBE AND INLET TUBE OF THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH EITHER CYLINDER. TOW SUTURES WERE ATTACHED TO BOTH CYLINDERS. BASED ON EXAMINATION OF THE RETURNED PRODUCT, IT WAS CONCLUDED THAT WHILE IN-VIVO BOTH THE EXHAUST TUBES AND INLET TUBE OF THE PUMP HAD OVERLAPPED AND ABRADED AGAINST ONE ANOTHER. THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, MAY CONTRIBUTE TO SUFFICIENT STRESS(S) TO SEPARATE ONE OF THE EXHAUST TUBING AT THIS SITE. A SEPARATION OF THIS TYPE COULD THEN ALLOW THE LOSS OF FLUID, MAKING THE DEVICE INOPERABLE. D4 LOT NUMBER: 5222644.

    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, CYLINDER TUBING LEAK. DEVICE REVISED THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE, AND NO TRENDS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496789 TITAN INFLATABLE PENILE PROTHESIS FHW COLOPLAST A/S QNR9161020

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR