BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX XTENDER

    MDR report key: 16919846 · Received May 11, 2023

    Report

    Report Number
    MW5117499
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 9, 2023
    Manufacturer
    UNKNOWN
    Product Code
    LKY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WWW.MASSIVENOVELTIES.COM SELL A DEVICE MARKETED AT STRETCHING THE MALE GENITALIA. USING THIS DEVICE DAMAGED MY OWN, RESULTING IN A LACK OF FUNCTION. AVR NOVELTIES LLC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352315 APEX XTENDER DEVICE, EXTERNAL PENILE RIGIDITY LKY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H