BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN

    MDR report key: 12357696 · Received August 24, 2021

    Report

    Report Number
    2125050-2021-01187
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    February 5, 2020
    Report Date
    August 24, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS CREATED AS AN ADDITIONAL FOLLOW-UP TO MDR RECORD # 2125050-2020-00351, INITIALLY REPORTED ON 22-APR-2020 THROUGH ESUBMITTER. THIS MDR IS TO REFLECT THE ADDITIONAL INFORMATION RECEIVED. A TITAN OTR PUMP, AND TWO CYLINDERS WERE RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A SEPARATION IN THE PUMP INLET TUBING AT THE TUBING/STRAIN RELIEF JUNCTION. TESTING REVEALED THIS TO BE A SITE OF LEAKAGE. MICROSCOPIC INSPECTION REVEALED AN AREA OF ABRASION, INDICATING THAT THE TUBING HAD BEEN KINKED AND ABRADING AGAINST ITSELF FOR SOME TIME. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDER 1 OR CYLINDER 2. BASED ON EXAMINATION OF THE RETURNED PRODUCT, IT WAS CONCLUDED THAT THE ABRASION MARK NOTED ON THE PUMP INLET TUBING, INDICATING IT HAD KINKED AND ABRADED AGAINST ITSELF FOR A PERIOD OF TIME WHILE IN-VIVO. THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, MAY HAVE CONTRIBUTED SUFFICIENT STRESS(S) TO CAUSE A SEPARATION OF THE PUMP INLET TUBING AT PUMP INLET TUBING/STRAIN RELIEF JUNCTION. A SEPARATION OF THIS TYPE COULD THEN ALLOW THE LOSS OF FLUID, RENDERING THE DEVICE INOPERABLE. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    ACCORDING TO AVAILABLE INFORMATION, CYLINDER LEAK (HOLES). PUMP TUBING LEAK (TEAR). ONLY PUMP REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256439 TITAN INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QNR9181022 4241669

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR