BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVO

    MDR report key: 15752755 · Received November 7, 2022

    Report

    Report Number
    MW5113105
    Event Type
    Injury
    Date Received
    November 7, 2022
    Date of Event
    October 18, 2022
    Report Date
    October 21, 2022
    Manufacturer
    ATLANTIC THERAPEUTICS LIMITED
    Product Code
    QAJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED AN INNOVO GARMENT IN SEPT. I AM A RETIRED PHYSICIAN AND FOLLOWED INSTRUCTIONS FOR CARE AND USE OF THIS GARMENT. THOUGH THEIR PRIMARY RECOMMENDATION WAS TO USE THIS GARMENT WHILE STANDING, DUE TO MY AGE AND MEDICAL ISSUES I ELECTED TO POSITION MYSELF LAYING DOWN, WHICH WAS ONE OF THEIR ALTERNATIVE RECOMMENDATIONS. ALL WAS GOING WELL UNTIL (B)(6) 2022. THE CONTROLLER WAS BEEPING WITH ELECTRODE WARNINGS. I FINALLY REMOVED THE GARMENT, AND UNPLUGGED EVERYTHING. I RESPRAYED ALL ELECTRODES WITH THE CONDUCTIVE SPRAY PROVIDED BY THE MANUFACTURER, PUT IT BACK ON, RECONNECTED AND TRIED TO START OVER. IT DELIVERED ONE SEEMINGLY NORMAL STIMULATION, AND THEN WITHOUT WARNING IT DELIVERED A POWERFUL ELECTRIC SHOCK TO MY LEFT HIP. IT LEFT A RED AREA AT THE SITE AND CAUSED PAIN TO ALL OF THE SURROUNDING MUSCLES. THE SHOCK WAS SIGNIFICANT ENOUGH TO CAUSE MY LEFT LEG TO STRAIGHTEN AND SEND ALL OF THE MUSCLES IN THE LEFT LEG, HIP, PELVIS AND TRUNK INTO SEVERE SPASM. THE PAIN WAS INTENSE. WHEN I HAD RECUPERATED ENOUGH, I CONTACTED THE COMPANY. WHILE ON THE PHONE I DID AN ONLINE SEARCH AND DISCOVERED NUMEROUS OTHER REPORTS OF SIMILAR ISSUES. THE REPRESENTATIVE NEVER ASKED IF I WERE OK. SHE ASKED THE GARMENT SIZE, IF I HAD A RED MARK, AND IF THE SHORTS WERE SNUG OR BAGGY. WHEN PRESSED, SHE ADMITTED THAT I WAS "BY FAR" NOT THE FIRST PERSON TO REPORT THIS. I ASKED WHY THE COMPANY RECOMMENDED A STANDING POSTURE AND LET HER KNOW THAT HAD I BEEN STANDING I WOULD HAVE, WITHOUT QUESTION, FALLEN AND GOTTEN INJURED WORSE. HIP FRACTURES, SUBDURAL HEMATOMA, THESE ARE ALL REAL ISSUES IN ELDERLY PATIENTS. SHE INFORMED ME THAT SHE WOULD PASS THIS ALONG, BUT THAT SHE WAS JUST AUTHORIZED TO EITHER ARRANGE A REPLACEMENT OR RETURN OF THE ITEM. THERE WAS A CONCERNING LACK OF INTEREST IN PATIENT SAFETY ON THEIR PART. I WAS LEFT WITH SEVERAL DAYS OF HIP AND BACK PAIN. IT IS 3 DAYS LATER AND I HAVE YET TO LEAVE THE HOUSE. SHORT OF THESE NUMEROUS REPORTS OF SEVERE ELECTRIC SHOCK, THERE ARE EVEN MORE CUSTOMER COMPLAINTS OF FAULTY ELECTRODES, AND MANY REPORTS THAT THIS HAPPENS AFTER APPROX 3-4 WEEKS OF USE. THIS WAS THE TIME FRAME IN MY CASE AS WELL. I BELIEVE THAT THIS NEEDS TO BE LOOKED AT. AT THE VERY LEAST, SPEAKING AS A PHYSICIAN, THE COMPANY SHOULD REMOVE THE RECOMMENDATION TO USE THE GARMENT STANDING, AND ISSUE A WARNING. THOUGH THEY DO NOT SOME ISSUES OF STRONGER STIMULATION, THIS IS GREATLY DOWNPLAYED. TO BE CLEAR, THIS WAS A SEVERE SHOCK LEADING TO SPASMS THAT RESEMBLED A CONVULSION AND LEFT ME TEMPORARILY INCAPACITED WITH NO CONTROL OVER MY LEG OR LEFT SIDE. I HAD TO GRAB THE WIRES AND DETACHED THE CABLE WITH MY RIGHT HAND TO GET THE SHOCK TO STOP. PLEASE WILL YOU INVESTIGATE THIS AND DO SOMETHING TO ADDRESS PATIENT SAFETY. IT IS MY HOPE THAT SHARING THIS INFORMATION WILL HELP TO PREVENT SERIOUS INJURY OR DEATH FROM SEQUELAE (SUCH AS A FALL) TO ANOTHER PATIENT. FEEL FREE TO CONTACT ME AT:(B)(6) WITH ANY QUESTIONS. :(B)(6), MD (RET.) FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212625 INNOVO CUTANEOUS ELECTRODE STIMULATOR FOR URINARY INCONTINENCE QAJ ATLANTIC THERAPEUTICS LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other AZOTHIOPRINE | BABY ASA | MELOXICAM | PREDNISONE PRN| PRILOSEC BID