BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESTOPEL TROCAR DEVICE

    MDR report key: 6092432 · Received November 7, 2016

    Report

    Report Number
    MW5065955
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    January 1, 2016
    Report Date
    November 7, 2016
    Manufacturer
    UNK
    Product Code
    GCJ
    UDI-DI
    66887000410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS THAT A FEW OF THE PELLETS HAVE COME OUT AFTER THE PROCEDURE. "ONGOING". NAME AND STRENGTH: TESTOPEL 15MG. DOSE OR AMOUNT: 75 MG. FREQUENCY: QUM. ROUTE: SQ. DATES OF USE: (B)(6) 2015 - ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734955 TESTOPEL TROCAR DEVICE TESTOPEK TROCAR DEVICE GCJ UNK P1410 66887000410

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR