Description of Event or Problem · 1
UNWITNESSED FALL, RESIDENT WAS FOUND BY SINK IN ROOM STILL IN MERRYWALKER BUT TIPPED OVER. 5CM HEMATOMA ON HEAD WITH 2.5 CM CUT WHICH BLED PROFUSELY. COMPLAINED OF (L) ELBOW & (L) HIP PAIN. FOLLOW-UP X-RAYS OF ELBOW & HIP WERE NEGATIVE. RESIDENT HAD USED MERRYWALKER ON A DAILY BASIS & SEEMED TO ENJOY GETTING AROUND BETTER THAN MANUVERING WHEELCHAIR. SHE IS NOW BACK IN WHEELCHAIRINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.