INDENT-A-BAND

Description of Event or Problem

PATIENT WAS NOTED TO HAVE A REDDENED AREA ON HER L CORSID WHICH IS ABOUT 1-1/2" DIAM. & LOOKS WEEPY AND MOIST. PT APPARENTLY UNAWARE OF ITS EXISTENCE. CAUSE UNKNOWN. THERE ARE TWO SMALL 1/2" DIAM. BRUISES JUST ABOVE RED AREA ON ARMDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.