BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 19351059 · Received May 20, 2024

    Report

    Report Number
    2125050-2024-00776
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    April 18, 2024
    Report Date
    July 23, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932460071
    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, CYLINDERS 1 AND 2, AND RESERVOIR WERE RECEIVED FOR EVALUATION. ABRASION WAS NOTED ON BOTH EXHAUST TUBES AND THE INLET TUBE OF THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDER 1 OR CYLINDER 2. A GROUP OF STRIATIONS, INDICATING CONTACT WITH UNSHOD INSTRUMENTATION, WAS NOTED ON THE INLET TUBE OF THE RESERVOIR. THIS IS A SITE OF LEAKAGE. THE INFORMATION RECEIVED INDICATED THE DEVICE HAD A TUBING LEAKAGE, BUT BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS BESIDES INSTRUMENT DAMAGE, 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. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED TO BE ASSOCIATED.

    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.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A TUBING LEAKAGE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A TUBING LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856826 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S 5361923_QNR9181022 05708932460071

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Required Intervention