BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVO

    MDR report key: 14161647 · Received April 19, 2022

    Report

    Report Number
    MW5109178
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 16, 2022
    Manufacturer
    ATLANTIC THERAPEUTICS LIMITED
    Product Code
    QAJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BAD ELECTRICAL SHOCK; WHILE USING MY INNOVO, I GOT AN ELECTRICAL SHOCK FROM THE SHORTS. I COMPLAINED TO THE COMPANY AND THEY SEND ME OUT A NEW PAIR OF SHORTS. THESE THEN ALSO ELECTROCUTED ME. THE COMPANY THEN OFFER ME A COMPLETELY DIFFERENT PRODUCT ADMITTING THAT THESE SHORTS ARE FAULTY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625869 INNOVO CUTANEOUS ELECTRODE STIMULATOR FOR URINARY INCONTINENCE QAJ ATLANTIC THERAPEUTICS LIMITED
    2625870 INNOVO CUTANEOUS ELECTRODE STIMULATOR FOR URINARY INCONTINENCE QAJ ATLANTIC THERAPEUTICS LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other VIT C| VIT D