BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE COVER PATCHES

    MDR report key: 13782806 · Received March 16, 2022

    Report

    Report Number
    0002242816-2022-00029
    Event Type
    Injury
    Date Received
    March 16, 2022
    Date of Event
    February 16, 2022
    Report Date
    March 15, 2022
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    UDI-DI
    00812301020195
    PMA / PMN Number
    P850022/S017
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). DATE OF EVENT: (B)(6) 2022. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT THE PATIENT'S COVER PATCHES ARE CAUSING A SKIN IRRITATION, AND THE 72R ELECTRODES ARE NOT STICKING. THE PATIENT HAD AN IRRITATION TO THE COVER PATCHES BACK IN (B)(6) 2021 WITH HER OLD SPAK UNIT. THE PATIENT NEEDED THE COVER PATCHES BECAUSE THE 72R ELECTRODES WERE NOT STICKING PROPERLY. THE PATIENT CLAIMS HER SKIN WAS RED, ITCHY, AND RAW WITH ULCERS. THERE WERE NO BLISTERS OR WELTS. THE PATIENT CLAIMS SHE ROTATED THE LOCATION DAILY, AND SHE USED NEW ELECTRODES AND COVER PATCHES DAILY. THE PATIENT CLAIMS THE IRRITATION BEGAN OUTSIDE THE CIRCULAR SHAPE OF THE ELECTRODES, AND IT WAS FROM THE COVER PATCHES. SHE STOPPED USING THE COVER PATCHES, AND THE IRRITATION GOT BETTER; SHE THEN BOUGHT SURGICAL SILICONE TAPE FROM THE DRUG STORE, AND THE IRRITATION RETURNED FROM THE TAPE. THE PATIENT SOUGHT ADVICE OF HER DERMATOLOGIST, AND SHE SUGGESTED A SILICONE GLOVES CREAM ON THE SKIN. THE PATIENT CLAIMS THIS CAUSED AN IRRITATION AS WELL. THE PATIENT DETERMINED THAT SHE HAS A SENSITIVITY TO SILICONE. HER FIRST SPAK WAS DISCONTINUED BY HER SURGEON SOON AFTER. RECENTLY, A REPLACEMENT UNIT WAS APPROVED AND SHIPPED TO THE PATIENT. 63B ELECTRODES HAVE BEEN SENT TO THE PATIENT, AND CUSTOMER SERVICE EXPLAINED HOW TO ACTIVATE THE ELECTRODES FOR A BETTER ADHESION TO THE SKIN, SO SHE DOESN'T NEED A COVER PATCH OR TAPE. THE PATIENT ALSO AGREES TO PERFORM A TIME TEST. AN EXAMPLE OF THE OLD 72R ELECTRODES WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245898 ELECTRODE COVER PATCHES ELECTRODE COVER PATCHES LOF EBI, LLC. N/A 115141 00812301020195

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention