BEUDAMED
    FDA Adverse Event Other Summary report: N

    TMAX & DISPOSABLE FACE MASK FOR POSITIONING

    MDR report key: 2508474 · Received February 14, 2012

    Report

    Report Number
    9681741-2011-00001
    Event Type
    Other
    Date Received
    February 14, 2012
    Date of Event
    January 7, 2011
    Report Date
    February 11, 2011
    Manufacturer
    TENET MEDICAL ENGINEERING
    Product Code
    BWN
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTS FROM THE HEALTH CARE PROVIDER INDICATED THAT THE INJURY TO THE PT WAS MINOR AS HEALING WAS EXPECTED TO OCCUR WITHOUT MEDICAL OR SURGICAL INTERVENTION. THE HEALTH CARE PROVIDER AND THE MFR AGREE THAT THE CAUSE OF THE INJURY WAS DUE TO THE EXCEPTIONALLY LONG DURATION OF THE PROCEDURE IN CONJUNCTION WITH THE MASK POTENTIALLY BEING TOO TIGHT AT THE BEGINNING OF THE SURGERY OR BECOMING TOO TIGHT AS A RESULT OF PT MOVEMENT DURING THE PROCEDURE. IT WAS DISCOVERED THAT THE PT LEG RESTRAINT WAS NOT BEING USED APPROPRIATELY AND MAY HAVE CONTRIBUTED TO PT MOVEMENT IF MOVEMENT OCCURRED.

    Description of Event or Problem · 1

    A PRESSURE ULCER DEVELOPED ON A PT'S CHIN AREA UNDER THE "DISPOSABLE FACE MASK FOR POSITIONING" DURING A BEACH CHAIR SHOULDER SURGERY, PROLONGED (7HRS) PRESSURE WAS DELIVERED TO THE PTS CHIN FROM A FACE MASK INTENDED TO STABILIZE THE PT'S HEAD DURING SURGERY. IN DISCUSSIONS WITH THE HEALTH CARE PROVIDER THEY INDICATED THAT THE HOSP MAY NOT HAVE APPLIED THE LEG BELT IN THE APPROPRIATE POSITION, AND THAT DURING THE UNUSUALLY LONG PROCEDURE THE PT MAY HAVE SHIFTED SLIGHTLY CAUSING ADDITIONAL PRESSURE TO THE AREA. INITIAL DISCUSSIONS WITH THE HEALTH CARE PROVIDER INDICATED THAT THE PT WOULD RECOVER FROM THE INJURY WITHOUT MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMAX & DISPOSABLE FACE MASK FOR POSITIONING BEACH CHAIR AND FACE MASK BWN TENET MEDICAL ENGINEERING 74-00-04 R1 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1