BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN

    MDR report key: 10841500 · Received November 15, 2020

    Report

    Report Number
    3003814961-2020-00003
    Event Type
    Malfunction
    Date Received
    November 15, 2020
    Date of Event
    September 11, 2020
    Report Date
    June 10, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A TITAN OTR PUMP AND CYLINDERS WERE RECEIVED FOR ANALYSIS. A SEPARATION WITHIN ABRASION WAS NOTED ON THE SHORTER EXHAUST TUBE AT THE TUBE/STRAIN RELIEF JUNCTION OF THE PUMP. THIS IS A SITE OF LEAKAGE. ABRASION WAS ALSO NOTED ON THE INLET TUBE OF THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH EITHER CYLINDER. BASED ON RECREATION OF THE POSITION OF THE TUBES ACCORDING TO THE ABRASION PATTERN, THIS DEMONSTRATES THAT THE SHORTER EXHAUST TUBE AND INLET TUBE OF THE PUMP MAY HAVE BEEN OVERLAPPING WHILE IN VIVO. THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, MAY CONTRIBUTE TO SUFFICIENT STRESS(S) TO CAUSE A SEPARATION THROUGH THE SHORTER EXHAUST TUBING. A SEPARATION OF THIS TYPE MAY THEN ALLOW THE LOSS OF FLUID, MAKING THE DEVICE INOPERABLE.

    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, PUMP TUBING LEAK (TEAR), THE DEVICE WAS REVISED/REPLACED. AVAILABLE FOR RETURN. THE LOT NUMBER 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
    1306850 TITAN INFLATABLE PENILE PROTHESIS FHW COLOPLAST A/S QNR9181022 5491288

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR