BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL SIGNS¿ HEAD POSITIONER

    MDR report key: 14811907 · Received June 25, 2022

    Report

    Report Number
    3013421741-2022-00015
    Event Type
    Injury
    Date Received
    June 25, 2022
    Date of Event
    September 11, 2019
    Report Date
    September 13, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CCX
    UDI-DI
    00749756999007
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). NO PHOTOGRAPHIC EVIDENCE WAS SUPPLIED AND NO SAMPLE WAS RETURNED. THE DEVICE USED ON THE PATIENT WAS DISCARDED AND THEREFORE THE REPORTED DEFECT COULD NOT BE CONFIRMED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8000 HDP VITAL SIGNS¿ HEAD POSITIONER CAUSED PRESSURE WOUND TO A PATIENT WHEN USED. THE BURNS WERE SEEN ON THE FOREHEAD NEAR THE EYEBROWS. THE CUSTOMER REPORTED IT IS A PRESSURE WOUND THAT CAUSED MULTIPLE BURN WOUNDS ON THE FACE WITH BREAKAGE OF THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056290 VITAL SIGNS¿ HEAD POSITIONER SUPPORT, PATIENT POSITION CCX VYAIRE MEDICAL VITAL SIGNS¿ HEAD POSITIONER 00048523724 00749756999007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other