TMAX & DISPOSABLE FACE MASK FOR POSITIONING

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.