MalfunctionIQI
TA / WALKING BOOT
Received Apr 21, 2016 · Event occurred Apr 10, 2016
Report 5593436 · MDR key 5593436
Device
Generic name
Component, External, Limb, Ankle/foot
Manufacturer
Restorative Care Of America, Inc.Model number
TA SERIESCatalog number
78TA SERIES
Product problems
- Mechanics Altered
Patient
16 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE TWO SIDE SCREWS - THAT THE SIDE SUPPORTS VERTICALLY - FELL OUT, THE SCREWS WERE REATTACHED. THE CLINIC REPORTED THIS IS NOT THE FIRST TIME THIS HAS HAPPENED WITH THIS BOOT, FROM THIS MANUFACTURER, ON OTHER PATIENTS. MANUFACTURER RESPONSE FOR WALKING BOOT, TA / WALKING BOOT (PER SITE REPORTER): THE CLINIC HAS INFORMED THE MANUFACTURER MORE THAN ONCE ABOUT THIS RECURRING PROBLEM. UNKNOWN RESPONSE. CLINIC WILL NO LONGER USE THIS MANUFACTURER AS THE PROBLEM IS NOT BEING CORRECTED.