BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 22804935 · Received August 14, 2025

    Report

    Report Number
    2125050-2025-01317
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    July 1, 2025
    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 AND CYLINDERS 1 AND 2 WERE RECEIVED FOR EVALUATION. A SEPARATION WAS NOTED ON THE SHORTER EXHAUST TUBING OF THE PUMP AT THE STRAIN RELIEF JUNCTION. THIS WAS A SITE OF LEAKAGE. THE SURFACES APPEAR TO BE ROUGH AND IRREGULAR, INDICATING STRESS WAS EXERTED. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDER 1 OR CYLINDER 2. BASED ON EXAMINATION OF THE RETURNED PRODUCT, IT WAS CONCLUDED THAT THE ROUGH AND IRREGULAR SURFACES ASSOCIATED WITH THE SEPARATION INDICATE THAT SUFFICIENT STRESS WAS EXERTED ON THE SHORTER EXHAUST TUBE NEAR THE PUMP TO SEPARATE THE SITE WHILE IN-VIVO. 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, 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
    1557367 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S 4640760_QNR9161022 05708932460057

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown Required Intervention