BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    40544 PINK ARC - STANDARD

    MDR report key: 16434976 · Received February 24, 2023

    Report

    Report Number
    16434976
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    January 31, 2023
    Report Date
    February 14, 2023
    Manufacturer
    XODUS MEDICAL, INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    POSITIONING DEVICE PLACED UNDER KNEES FOR SURGERY. THERMAL WARMING PAD USED ON TOP OF FOAM POSITIONING DEVICE. BURNS NOTED TO THE BACK OF THE KNEES AT THE END OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959664 40544 PINK ARC - STANDARD SUPPORT, PATIENT POSITION CCX XODUS MEDICAL, INC. 40544

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA Male Other