MalfunctionISH
VARI-FLEX PYR EVO C8 S28HH
Received Sep 25, 2014 · Event occurred Aug 23, 2014
Report 3003764610-2014-00004 · MDR key 4189231
Device
Product problems
- Break
Patient
Not reported
- Fall
- Head Injury
Narrative
Additional Manufacturer Narrative
SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION AND ANALYSIS.
Description of Event or Problem
BELOW KNEE AMPUTEE PATIENT WAS GOING UP A FLIGHT OF STAIRS WHEN THE PYRAMID ADAPTER BROKE CAUSING HIM TO FALL. THE PATIENT HIT HIS HEAD AND WENT TO THE DOCTOR. NO FURTHER ATTENTION WAS NEEDED AS HE IS RECOVERING WELL AND WILL REACH FULL RECOVERY.