BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN

    MDR report key: 12530729 · Received September 25, 2021

    Report

    Report Number
    2125050-2021-01374
    Event Type
    Injury
    Date Received
    September 25, 2021
    Report Date
    November 1, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932539197
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A TITAN TOUCH PUMP AND DETACHED INLET TUBING WITH CONNECTOR WERE RETURNED FOR ANALYSIS. A SEPARATION WITHIN ABRASION WAS NOTED ON THE LONGER EXHAUST TUBE OF THE PUMP. THIS WAS A SITE OF LEAKAGE. PARTIAL SEPARATIONS WITHIN ABRASION WERE NOTED ON BOTH EXHAUST TUBES. THESE WERE NOT SITES OF LEAKAGE. ABRASION WAS NOTED ON THE INLET TUBE OF THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE DETACHED INLET TUBE OR CONNECTOR. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE DETACHED INLET TUBE OR CONNECTOR. 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. 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. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED,THERE WAS A FRACTURE IN THE PUMP TUBING OF A TITAN OTR. THE DEVICE WAS EXPLANTED AND REPLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428371 TITAN INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29202400 6247947 05708932539197

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention