VARIFLEX PYRAMID EVO UNITY C8
Received Oct 27, 2015 · Event occurred May 18, 2015
Report 3003764610-2015-00013 · MDR key 5180370
Device
Generic name
Component, External, Limb, Ankle/foot
Manufacturer
Ossur IcelandModel number
VFPU8280Catalog number
VFPU8280
Product problems
- Component Incompatible
Patient
Not reported
- Fall
Narrative
Additional Manufacturer Narrative
SAFETY ALERT SENT TO CUSTOMERS TO REMIND THEM TO ONLY USE OSSUR COMPONENTS IN FOOT ASSEMBLIES. COMPETITOR PRODUCTS ARE NOT COMPATIBLE AND MAY CAUSE EARLY FAILURE.
Description of Event or Problem
BELOW KNEE AMPUTEE PATIENT IS ACTIVE AND VERY MOBILE. THE PATIENT WAS WALKING ON THE GRASS AND STEPPED OVER A HOSE ON THE GROUND. AS HE WAS STEPPING FORWARD, THE PYRAMID SHEARED OFF AND HE FELL. THE FOOT HIT HIM IN THE HEAD. HE WAS SLIGHTLY BRUISED BUT NOT INJURED AND DID NOT REQUIRE ANY MEDICAL INTERVENTION.
Remedial action
- Modification/Adjustment
- Notification