BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFENDER

    MDR report key: 24518509 · Received March 5, 2026

    Report

    Report Number
    3016000973-2026-00001
    Event Type
    Injury
    Date Received
    March 5, 2026
    Date of Event
    February 10, 2026
    Report Date
    February 12, 2026
    Manufacturer
    PRECISION MEDICAL PRODUCTS, INC
    Product Code
    JOW
    UDI-DI
    00194832000052
    PMA / PMN Number
    K212731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS WEARING DEVICE ON CALF OF LEFT LEG. STAFF NOTED PATIENT HAD A DEGREE OF LACK OF SENSITIVITY ON LEFT LEG AND PATIENT IS POSITIVE FOR MRSA. VA NURSING STAFF WAS REVIEWING THE PATIENT'S SKIN AND IDENTIFIED SKIN INJURY, THEN THEY CONTACTED WOUND NURSE, WHO CONSULTED FOR WOUND ORDER. THE WOUND RN COULDN'T FOR SURE DETERMINE IF IT WAS A WOUND, BURN OR MED DEVICE RELATED INJURY, BUT WHERE THE "WOUND" WAS IS RIGHT UNDER WHERE THE BATTERY PACK WAS RESTING. STAFF TOOK OFF DEFENDERS AND LEFT THEM OFF. AND HAVE DISCONTINUED USE FOR THE WHOLE FLOOR FOR THE TIME BEING. PATIENT WAS FORWARDED TO THE WOUND TEAM AND DEVELOPED A PLAN OF CARE. RECOVERY AND STATUS UPDATE OF THE PATIENT'S SKIN CONDITION IS STILL UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576372 DEFENDER DEEP VEIN THROMBOSIS PREVENTION SLEEVE JOW PRECISION MEDICAL PRODUCTS, INC 08-0028 00194832000052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O