BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN

    MDR report key: 13213754 · Received January 10, 2022

    Report

    Report Number
    2125050-2022-00024
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    January 1, 2022
    Report Date
    March 1, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    TITAN OTR PUMP AND CYLINDERS 1 AND 2 WERE RECEIVED FOR EVALUATION. PARTIAL SEPARATIONS WITHIN ABRASION WERE NOTED ON THE LONGER EXHAUST TUBE AND INLET TUBE OF THE PUMP. THESE WERE NOT SITES OF LEAKAGE. ABRASION WAS ALSO NOTED ON THE SHORTER EXHAUST TUBE OF THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH EITHER CYLINDER. TWO SUTURES WERE ATTACHED TO BOTH CYLINDERS. THE INFORMATION RECEIVED INDICATED THERE WAS PUMP TUBING LEAKAGE, 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.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A PUMP TUBING LEAK. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589631 TITAN INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QNR9161022 4021122

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention