BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULES NIGHT RIDER

    MDR report key: 15242887 · Received August 16, 2022

    Report

    Report Number
    MW5111541
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    August 13, 2022
    Report Date
    August 15, 2022
    Manufacturer
    UNK
    Product Code
    LKY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USE OF AN OTC DEVICE CALLED "HERCULES NIGHT RIDER" PURCHASED AT A LOCAL STARSHIP. DEVICE IS SOLD AS A "NOVELTY" AND CONTAINS ONLY USE WARNINGS NOT TO USE ON SWOLLEN OR LACERATED AREAS. SUBJECT EXPERIENCED GRADE 3 PENILE BRUISING IN THREE AREAS ON THE PENILE SHAFT JUST TRYING TO PLACE THE DEVICE. PENILE SHAFT IS SEVERELY BRUISED AND SORE. SELLER OF THE DEVICE HAS BEEN NOTIFIED OF THE INJURY ON (B)(6) 2022. RESPONSE IS PENDING. NO LABORATORY TESTS REQUIRED. STARSHIP IS THE COMPANY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848253 HERCULES NIGHT RIDER DEVICE, EXTERNAL PENILE RIGIDITY LKY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Unknown Other AMITRYPTILINE | MULTIVITAMIN| TESTERONE