BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN OTR

    MDR report key: 12263747 · Received August 2, 2021

    Report

    Report Number
    2125050-2021-01033
    Event Type
    Injury
    Date Received
    August 2, 2021
    Date of Event
    June 25, 2021
    Report Date
    October 20, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FWH
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TITAN OTR PUMP, AND CYLINDERS 1 AND 2 WERE RECEIVED FOR ANALYSIS. A SEPARATION WITH ABRASION ADJACENT WAS NOTED ON THE SHORTER EXHAUST TUBE OF THE PUMP. THIS WAS A SITE OF LEAKAGE. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH EITHER CYLINDER. BASED ON EXAMINATION OF THE RETURNED PRODUCT, THE ABRASION MARK NOTED ADJACENT TO THE SEPARATION IN THE SHORTER EXHAUST TUBE OF THE PUMP INDICATED THAT IT HAD KINKED ONTO ITSELF FOR A PERIOD OF TIME WHILE IN VIVO. THE ABRASION THEN RESULTED IN THE SEPARATION NOTED IN THE TUBING. 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

    THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, A PUMP TUBING FRACTURE OCCURRED. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155427 TITAN OTR INFLATABLE PENILE PROSTHESIS FWH COLOPLAST A/S QNR9161022 5537053

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention