BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE COVER PATCHES

    MDR report key: 11971195 · Received June 9, 2021

    Report

    Report Number
    0002242816-2021-00093
    Event Type
    Injury
    Date Received
    June 9, 2021
    Report Date
    May 30, 2024
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    P850022/S017
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS - B1, B4: DATE OF THIS REPORT ADDED, B5: UPDATED THE PRODUCT WAS NOT RETURNED FOR EVALUATION, D3: MANUFACTURER ADDRESS AND EMAIL ADDRESS, D4: UDI, D5, D8: DEVICE NOT SERVICED BY 3RD PARTY, G1: CONTACT OFFICE AND MANUFACTURER SITE, G6: REPORT TYPE ADDITIONAL INFORMATION - H4: DEVICE MANUFACTURE DATE, H6: IMPACT CODE, METHOD, RESULTS, AND CONCLUSIONS, H10: ADDITIONAL NARRATIVE, H11. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE DEVICE WAS NOT RETURNED TO (B)(6) MEDICAL FOR EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. (B)(6) MEDICAL WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT STATED SHE CANNOT USE 72R ELECTRODES DUE TO RASH/BURNS CAUSED BY THE PADS. THE PATIENT WEARS A BRACE ON HER NECK. THE PATIENT WAS NOT SURE IF ITS THE ELECTRODES OR BURNS. THE PATIENT THINKS IT WAS THE COVERS. THE PATIENT DESCRIBES THE SKIN AS SCABBED OVER/PEELING. THE PATIENT HAS APPLIED LOTIONS- ITCH LOTION. MOISTURIZER AND ANTISEPTIC. THE PATIENT STATED THAT SHE DOE NOT HAVE SENSITIVE SKIN. THE PATIENT ROTATED THE ELECTRODES CHANGED THEM EVERYDAY. THE PATIENT WORE THE PRODUCTS FOR 23 HOURS. SHE STOPPED WEARING THE PRODUCTS AND THE SKIN STARTED TO HEAL. THE PATIENT WAS INSTRUCTED BY HER DOCTOR TO DISCONTINUE UNTIL THE SKIN WAS COMPLETELY CLEARED. SHE THINKS THE RASH/BURN IS FROM THE HEAT. THE PATIENT WAS SENT 63B ELECTRODES. SHE WILL CONDUCT TIMED TEST. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE. THE COVER PATCHES WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT CMP-(B)(4). DATE OF EVENT: THE EVENT OCCURRED SOMETIME IN (B)(6) 2021. MEDICAL PRODUCT: 5 X14 X11 MM PLATE CAGES. MEDICAL PRODUCT: RIGID CERVICAL COLLAR THERAPY DATE: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT THE PATIENT STATED SHE CANNOT USE 72R ELECTRODES DUE TO RASH/BURNS CAUSED BY THE PADS. THE PATIENT WEARS A BRACE ON HER NECK. THE PATIENT WAS NOT SURE IF ITS THE ELECTRODES OR BURNS. THE PATIENT THINKS IT WAS THE COVERS. THE PATIENT DESCRIBES THE SKIN AS SCABBED OVER/PEELING. THE PATIENT HAS APPLIED LOTIONS- ITCH LOTION. MOISTURIZER AND ANTISEPTIC. THE PATIENT STATED THAT SHE DOE NOT HAVE SENSITIVE SKIN. THE PATIENT ROTATED THE ELECTRODES CHANGED THEM EVERYDAY. THE PATIENT WORE THE PRODUCTS FOR 23 HOURS. SHE STOPPED WEARING THE PRODUCTS AND THE SKIN STARTED TO HEAL. THE PATIENT WAS INSTRUCTED BY HER DOCTOR TO DISCONTINUE UNTIL THE SKIN WAS COMPLETELY CLEARED. SHE THINKS THE RASH/BURN IS FROM THE HEAT. THE PATIENT WAS SENT 63B ELECTRODES. SHE WILL CONDUCT TIMED TEST. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867284 ELECTRODE COVER PATCHES COVER PATCHES LOF EBI, LLC. N/A 031440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention