CVS
Received Mar 9, 2016 · Event occurred Jan 23, 2016
Report 2438477-2016-00012 · MDR key 5489208
Device
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
62 YR
- Eye Injury
- Eye Injury
Narrative
Additional Manufacturer Narrative
THIS SUBMISSION PACKAGE WAS ORIGINALLY SUBMITTED ON (B)(4) 2016 USING THE TEST SITE BECAUSE I WAS UNAWARE OF THE PRODUCTION SITE. IT WILL BE REPACKAGE AND SEND THROUGH THE PRODUCTION SITE ON (B)(4) 2016.
Description of Event or Problem
DRIVE MEDICAL RECEIVED A NOTICE FROM AN END USER REGARDING AN INCIDENT WHICH INVOLVES A (B)(6) CANE THAT DRIVE MEDICAL IMPORTS. WHILE THE END USER WAS USING THE CANE, IT FOLDED AND COLLAPSED, CAUSING HIM TO HIT HIS HEAD ON THE MARBLE FLOOR. THE END USER SUFFERED SPLIT EYEBROW AND NERVE DAMAGE. ACCORDING TO HIS DOCTOR, HIS EYE WAS NOT WORKING PROPERLY. THE ITEM NUMBER AND SERIAL NUMBER IS UNKNOWN. THUS, WE CANNOT IDENTIFY THE MANUFACTURER. THE REPORT IS BASED ON INFORMATION PROVIDED BY THE END USER AND (B)(6).