BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOWAVE GOPADS 2IN ROUND 6/PK

    MDR report key: 16906790 · Received May 10, 2023

    Report

    Report Number
    2183164-2023-00151
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 21, 2023
    Report Date
    June 6, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER REVIEWING THE NEW INFORMATION PROVIDED IT WAS DETERMINED THAT THIS REPORT WAS SUBMITTED IN ERROR FOR THIS SPECIFIC OEM (OUTSIDE EQUIPMENT MANUFACTURER) AND PRODUCT ID, CARDINAL HEALTH IS NOT CONSIDERED TO BE THE MANUFACTURER SUBJECT TO THE REPORTING REQUIREMENTS OF THE MDR REGULATION AS THIS OEM REPACKAGES OR OTHERWISE CHANGES THE CONTAINER, WRAPPER, OR LABELING OF THIS DEVICE IN FURTHERANCE OF THE DISTRIBUTION OF THE DEVICE FROM THE ORIGINAL PLACE OF MANUFACTURE. PLEASE DISREGARD REPORT NUMBERS 2183164-2023-00151 & 2183164-2023-00152.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    CUSTOMER REPORTS: FOUR OF THE 6 ELECTRODES DEVELOPED BURNED HOLES IN THE PADS AND A BLACK ACCUMULATION ON THE WIRES. ONE SET REACHED 6 USES BEFORE THE HOLES APPEARED. AND THE SECOND SET REACHED 8 USES. THE THIRD SET FROM THIS LOT HAS NOT BEEN USED YET. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023, THE PATIENT EXPERIENCED REDNESS (EYRTHEMA) AND A SMALL BLISTER, APPROXIMATELY 1/2", MAINLY FROM THE WIRE AND NOT THE PAD ITSELF BUT IT IS HARD TO TELL. THERE WAS NO MEDICAL INTERVENTION, THE SKIN HEALS AFTER A FEW DAYS. THE PATIENT APPLIES A NEW SET OF ELECTRODES AND PLACES IT AWAY FROM THE BURN SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232024 BIOWAVE GOPADS 2IN ROUND 6/PK STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF GZJ CARDINAL HEALTH MK78563 927354

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown