RELIANCE 546 STOOL
Received Jul 22, 2009 · Event occurred Jun 23, 2009
Report 1523545-2009-00001 · MDR key 2624087
Device
Generic name
Stool, Anesthesia (brx)
Manufacturer
Reliance Medical ProductsModel number
546Catalog number
546
Lot number
0109010
Product problems
- Break
Patient
Not reported
- Fall
Narrative
Description of Event or Problem
WHILE USER WAS POSITIONING HER FOOT ON THE FOOTREST AND SHIFTING HER WEIGHT, A RING CLIP BROKE RESULTING IN THE USER FALLING. THE FALL RESULTED IN A TEARING OF AN ACL IN HER KNEE. SURGERY WAS REQUIRED TO REPAIR THE DAMAGED KNEE AREA.
Additional Manufacturer Narrative
DEVICE HAS NOT YET BEEN RETURNED TO RELIANCE MED PRODUCTS. ONLY A VISUAL REVIEW COULD BE PERFORMED AT USER FACILITY. ADD'L EVAL WILL BE PERFORMED UPON RECEIPT OF DEVICE. CONCLUSION: RESULTS OF THE VISUAL INSP OF SUSPECT DEVICE WERE INCONCLUSIVE. ATTEMPTS TO RECREATE FAILURE ON LIKE PRODUCT IN NORMAL USE SETTINGS DID NOT RESULT IN CLIP BREAKAGE. MISUSE OF PRODUCT CAN RESULT IN CLIP BREAKAGE.