BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER

    MDR report key: 19289803 · Received May 10, 2024

    Report

    Report Number
    3008933393-2024-00004
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    March 20, 2024
    Report Date
    May 10, 2024
    Manufacturer
    NISSHA MEDICAL TECHNOLOGIES
    Product Code
    GEI
    UDI-DI
    15060842920029
    PMA / PMN Number
    K203494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURING REVIEW WAS COMPLETED USING ALL ASSOCIATED RECORDS FOR PRODUCTION OF LOT 073082. THIS DID NOT HIGHLIGHT ANY ISSUES WITH THE LOT OR RAW MATERIAL USED. FURTHERMORE, THERE HAVE BEEN NO CONFIRMED COMPLAINTS AGAINST THIS LOT OR THE RAW MATERIAL LOT. IN THE COMPLAINT REPORT IT WAS STATED THAT THE PAD WAS POSITIONED IN A VERTICAL ORIENTATION ON THE CALF. THIS IS CONTRARY TO THE IFU INSTRUCTIONS WHICH REQUIRES THE LONG EDGE OF THE PAD TO FACE THE SURGICAL SITE, AND ADDITIONALLY STATES THAT THE THIGH IS THE PREFERRED LOCATION ON THE LEG. APPLICATION OF THE PRODUCT IN THIS WAY CAN AFFECT THE CURRENT DISTRIBUTION ACROSS THE PAD AND THEREFORE IS MORE LIKELY TO RESULT IN INCREASED TEMPERATURE AT THE SKIN SURFACE. THE CAUSE IS THEREFORE ASSIGNED AS USE ERROR

    Description of Event or Problem · 0

    IT WAS REPORTED TO NMT ON(B)(6) 2024 BY THE SALES REP THAT A PATIENT WAS BURNED BY A GROUNDING PAD. PATIENT WAS PRESCRIBED BURN MEDICATION. SALES REP STATED THE SITE PREP WAS DONE BUT THE PAD WAS PLACED ON THE CALF IN A VERTICAL ORIENTATION. BURN WAS SAID TO BE 1ST DEGREE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2529290 STRYKER NEUTRAL ELECTRODE GEI NISSHA MEDICAL TECHNOLOGIES 0406-650-205 073082 15060842920029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention