BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WITOUCH PRO

    MDR report key: 7675654 · Received July 10, 2018

    Report

    Report Number
    3008585473-2018-00106
    Event Type
    Injury
    Date Received
    July 10, 2018
    Date of Event
    July 9, 2018
    Report Date
    July 10, 2018
    Manufacturer
    HOLLYWOG, LLC
    Product Code
    NUH
    UDI-DI
    00853096004021
    PMA / PMN Number
    K171599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT. (CONSUMER) INDICATED HE HAS ATRIAL FIBRILLATION FROM A PREEXISTING CONDITION. THE WARNINGS! SECTION OF THE INSTRUCTIONS FOR USE STATES: DO NOT USE THIS DEVICE IF YOU ARE SUSCEPTIBLE TO RHYTHM DISTURBANCES TO THE HEART UNLESS UNDER THE DIRECTION OF YOUR PHYSICIAN. THE PT. STATED HE PURCHASED THE DEVICE ON THE INTERNET WITHOUT OBTAINING HIS PHYSICIAN'S ADVICE. HE AGREED NOT TO CONTINUE USING THE DEVICE UNTIL HE OBTAINS ADVICE FROM HIS PHYSICIAN. THE PT. STATED HE HAS USED OTHER MANUFACTURERS TENS DEVICES WHICH HE OBTAINED THROUGH HIS PHYSICIAN AT THE (B)(6). THE REPORT WAS NOT A PROBLEM WITH THE DEVICE, THEREFORE, THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DHR WAS REVIEWED WHICH SHOWED THE DEVICE PERFORMED TO SPECIFICATION WHEN IT WAS MANUFACTURED. THERE ARE NO SIMILAR REPORTS OF ATRIAL FIBRILATION FROM USE OF THE DEVICE. THE CONCLUSION IS THIS IS AN ISOLATED EVENT RELATED TO A PT. PREEXISTING CONDITION AND THE PT. DID NOT READ THE WARNINGS! SECTION OF THE INSTRUCTIONS FOR USE: DO NOT USE THIS DEVICE IF YOU ARE SUSCEPTIBLE TO RHYTHM DISTURBANCES TO THE HEART UNLESS UNDER THE DIRECTION OF YOUR PHYSICIAN.

    Description of Event or Problem · 1

    I PURCHASED THE DEVICE ON (B)(6) AND I EXPERIENCED ISSUES WITH MY AFIB SHORTLY AFTER THE FIRST USE OF THE DEVICE. I CONTACTED MY PRIMARY CARE PHYSICIAN AT THE (B)(6) TO SEE IF I CAN CONTINUE USING THE DEVICE. I WILL STOP USING THE DEVICE UNTIL MY DOCTOR TELLS ME IF I CAN CONTINUE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515256 WITOUCH PRO TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR FOR PAIN RELIEF NUH HOLLYWOG, LLC 11.1500 N/A 00853096004021

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability