POSEY PASTEL COTTON GAIT BELT 72"

Description of Event or Problem

CUSTOMER REPORTING A COMPLAINT ON PRODUCT 6531L GAIT BELT. CUSTOMER STATES THAT THERE IS A SHARED SAFETY CONCERN ON THE GAIT BELT. THE BELT COMES LOOSE VERY EASILY AND FREQUENTLY NEEDS TO BE ADJUSTED AND TIGHTENED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

Additional Manufacturer Narrative

WITHOUT THE RETURN OF THE DEVICE, CONFIRMATION OF THE CUSTOMER'S COMPLAINT AND THE ROOT CAUSE COULD NOT BE DETERMINED. THEREFORE, THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. THE PRODUCT LOT INFORMATION WAS NOT PROVIDED, THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED. A REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY SIMILAR EVENTS AGAINST THIS DEVICE IN THE PAST THREE YEARS. THEREFORE, IT APPEARS THIS COMPLAINT WAS AN ISOLATED EVENT. INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE INSTRUCTIONS FOR USE STATE: DURING THE APPLICATION OF THE BELT THE STRAP SHOULD LAY FLAT ACROSS THE BUCKLE. TUCK EXCESS UNDER THE BELT. ALWAYS VERIFY PROPER CLOSURE BEFORE USE. ALWAYS CHECK FOR SKIN INTEGRITY, PROPER CIRCULATION AND RANGE OF MOTION WHEN THE BELT IS IN USE. ENSURE THAT THE BELT IS SECURE AND DOES NOT COMPROMISE THE PATIENT¿S MEDICAL CONDITION AND DOES NOT INTERFERE WITH TUBES, LINES OR OTHER EQUIPMENT. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS A PART OF THE MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. MANUFACTURER REFERENCE FILE # (B)(4) (REPORT 2 OF 2).