MalfunctionITW
AIRCAST A60 ANKLE BRACE,L,RT
Received Oct 21, 2019 · Event occurred Sep 23, 2019
Report 9616086-2019-00074 · MDR key 9215111
Product problems
- Collapse
- Collapse
Patient
Not reported
- Fall
- Fall
Narrative
Additional Manufacturer Narrative
NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT "METAL STAYS POKING THROUGH CAUSING PATIENT TO FALL AND HURT HER LEG... THE STAYS ON THE BRACE BUCKLED WHILE SHE WAS WALKING, CAUSING HER TO FALL." THE PATIENT WAS WEARING THE BRACE DUE TO A FRACTURED ANKLE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.