BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 12263218 · Received August 2, 2021

    Report

    Report Number
    2125050-2021-01027
    Event Type
    Injury
    Date Received
    August 2, 2021
    Date of Event
    June 25, 2021
    Report Date
    October 12, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FWH
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TITAN TOUCH PUMP, CYLINDERS 1 AND 2, AND DETACHED INLET TUBE WITH CONNECTOR WERE RECEIVED FOR EVALUATION. PARTIAL SEPARATIONS WITH IN ABRASION WERE NOTED ON BOTH EXHAUST TUBES OF THE PUMP. TESTING REVEALED THESE TO NOT BE SITES OF LEAKAGE. ABRASION WAS ALSO NOTED ON THE INLET TUBE. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDER 1. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH DETACHED TUBE OR CONNECTOR. THE INFORMATION RECEIVED INDICATED THE DEVICE MALFUNCTIONED, BUT BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS, THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. 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, AN UNSPECIFIED MALFUNCTION OCCURRED. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161018 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FWH COLOPLAST A/S ES29161022 5120932

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention