BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENOTAC 2.0 MALE IMPLANT

    MDR report key: 16400133 · Received February 17, 2023

    Report

    Report Number
    3008650117-2023-00039
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 18, 2023
    Report Date
    February 17, 2023
    Manufacturer
    PARAGON 28, INC
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MALE IMPLANT BACKED OUT APPROXIMATELY 2 MONTHS POST-IMPLANTATION AFTER THE PATIENT STARTED AMBULATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263678 TENOTAC 2.0 MALE IMPLANT HWC PARAGON 28, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other