BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN

    MDR report key: 12025542 · Received June 18, 2021

    Report

    Report Number
    2125050-2021-00763
    Event Type
    Injury
    Date Received
    June 18, 2021
    Report Date
    September 23, 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 Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4 LOT NUMBER: 3951008. A TITAN PUMP AND TWO CYLINDERS WERE RECEIVED FOR ANALYSIS. A SEPARATION WITHIN ABRASION WAS NOTED ON THE LONGER EXHAUST TUBE OF THE PUMP AT THE TUBE/STRAIN RELIEF JUNCTION. THIS WAS A SITE OF LEAKAGE. PARTIAL SEPARATIONS WITHIN ABRASION WERE NOTED ON THE SHORTER EXHAUST TUBE OF THE PUMP. THIS WAS NOT A SITE OF LEAKAGE. ABRASION WAS ALSO NOTED ON THE INLET TUBE OF THE PUMP. ABRASION WAS NOTED ON THE EXHAUST TUBE OF CYLINDER 1. NO FUNCTIONAL ABNORMALITIES WERE NOTE WITH EITHER CYLINDER. BASED ON EXAMINATION OF THE RETURNED PRODUCT, IT WAS CONCLUDED THAT THE ABRASION MARKS NOTED ON ALL PUMP TUBING MATCHED IN SUCH A WAY TO CONCLUDE THAT THEY HAD OVERLAPPED AND ABRADED AGAINST ONE ANOTHER WHILE IN-VIVO. THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, MAY CONTRIBUTE TO SUFFICIENT STRESS(S) TO CAUSE A SEPARATION THROUGH THE LONGER EXHAUST TUBING AT THIS SITE. A SEPARATION OF THIS TYPE MAY THEN ALLOW THE LOSS OF FLUID, MAKING THE DEVICE INOPERABLE. 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.

    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.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THE TUBING TORE. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919810 TITAN INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES89202400 05708932487368

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention