BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPPER FIT COMPRESSION GLOVE

    MDR report key: 8922838 · Received August 21, 2019

    Report

    Report Number
    MW5089253
    Event Type
    Injury
    Date Received
    August 21, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 12, 2019
    Manufacturer
    IDEAVILLAGE PRODUCTS CORP.
    Product Code
    ILH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE SUBMITTER IS REPORTING THE PRODUCT FOR POSING A SAFETY HAZARD. HE CLAIMS THE PRODUCT CAUSED HIM ADVERSE HEALTH AND BEHAVIOR EFFECTS. WHILE HE HAD THE GLOVES ON HE TOUCHED HIS BACK ,WHERE HE HAD A PAIN STIMULATOR AND BEGAN TO FEEL ILL. HE BELIEVES THE METAL INSIDE THE GLOVES HAD A BAD REACTION WITH THE PAIN STIMULATOR AND HE BEGAN TO FEEL PAIN IN HIS BACK. HE THEN BEGAN TO FEEL PAIN IN HIS EYES, HIS EARS, AND HIS HEART. HE SAID ANYWHERE HE PUT HIS HANDS WITH THE GLOVES BEGAN TO HURT. HIS LEG BEGAN TO SHAKE AND HE STARTED THROWING UP. THE AMBULANCE AND POLICE WERE CALLED. HE SAID THE PRODUCT CAUSED HIM TO ACT VIOLENTLY AND HE WAS ARRESTED AND TAKEN TO THE HOSP. HE WAS ADVISED TO BE ON A 30 DAY WATCH BECAUSE HE WAS AT RISK OF DANGER. HE SAID HIS BLOOD PRESSURE WAS 408 / 32 BUT AFTER AN EVALUATION, THE DRS SAID HE WAS COMPLETELY HEALTHY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712745 COPPER FIT COMPRESSION GLOVE SPLINT, HAND, AND COMPONENTS ILH IDEAVILLAGE PRODUCTS CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR