BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 12263535 · Received August 2, 2021

    Report

    Report Number
    2125050-2021-01029
    Event Type
    Injury
    Date Received
    August 2, 2021
    Date of Event
    October 7, 2020
    Report Date
    August 2, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FWH
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, AN INFECTION OCCURRED. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160090 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FWH COLOPLAST A/S ES29181022 7012772

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention