BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 23430235 · Received October 30, 2025

    Report

    Report Number
    2125050-2025-01724
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 1, 2025
    Report Date
    January 22, 2026
    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

    TITAN OTR PUMP AND CYLINDERS 1 AND 2 WERE RECEIVED FOR EVALUATION. ABRASION WAS NOTED ON BOTH EXHAUST TUBES AND THE INLET TUBE OF THE PUMP. A SEPARATION, SURROUNDED BY ABRASION, WAS NOTED ON THE LONGER EXHAUST TUBING OF THE PUMP. THIS IS A SITE OF LEAKAGE. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDER 1 OR CYLINDER 2. BASED ON EXAMINATION OF THE RETURNED PRODUCT, IT WAS CONCLUDED THAT WHILE IN-VIVO BOTH THE EXHAUST TUBES AND INLET TUBE OF THE PUMP HAD OVERLAPPED AND ABRADED AGAINST ONE ANOTHER. THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, COULD CONTRIBUTE TO SUFFICIENT STRESS TO SEPARATE THE LONGER EXHAUST TUBING OF THE PUMP. A SEPARATION OF THIS TYPE COULD 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 · 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 TO BE ASSOCIATED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO TUBING LEAKAGE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO TUBING LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369082 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S 5073510_QNR9161022 05708932460057

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention