BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 12410660 · Received September 1, 2021

    Report

    Report Number
    2125050-2021-01246
    Event Type
    Injury
    Date Received
    September 1, 2021
    Report Date
    September 1, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FWH
    UDI-DI
    05708932539135
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REVIEW OF THE DEVICE LOT HISTORY RECORD INDICATES THIS LOT WAS PROCESSED THROUGH THE VALIDATED STERILIZATION CYCLE. THEREFORE, IT WAS CONCLUDED THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. 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, NON-CONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, AN INFECTION OCCURRED AND THE LEFT CORPORA HERNIATED. THE DEVICE WAS REPLACED WITH A MALLEABLE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305401 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FWH COLOPLAST A/S ES28202400 5212117 05708932539135

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention