BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 22810246 · Received August 14, 2025

    Report

    Report Number
    2125050-2025-01319
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    January 1, 2024
    Report Date
    October 20, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932460057
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED IN VEEVA TO BE ASSOCIATED.

    Additional Manufacturer Narrative · 0

    TITAN OTR PUMP, CYLINDERS 1 AND 2, AND RESERVOIR WERE RECEIVED FOR EVALUATION. ABRASION WAS NOTED ON BOTH EXHAUST TUBES AND THE INLET TUBE OF THE PUMP. PARTIAL SEPARATIONS, SURROUNDED BY ABRASION, WERE NOTED ON THE INLET TUBE OF THE PUMP. THESE WERE NOT SITES OF LEAKAGE. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. BOTH CYLINDERS WERE RECEIVED WITH TOW SUTURES STILL ATTACHED. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDER 1 OR CYLINDER 2.NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RESERVOIR. THE INFORMATION RECEIVED INDICATED THE DEVICE HAD 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, NONCONFORMANCE'S AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING LEAK.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956624 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S 5258474_QNR9161022 05708932460057

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention