InjuryILY
VECTRA GENYSIS COMBO
Received Apr 13, 2012 · Event occurred Feb 22, 2012
Report 9616086-2012-00022 · MDR key 2542612
Product problems
- Insufficient Device Problem Information
Patient
38 YR
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
ON (B)(6) 2012, RECEIVED A COMPLAINT THAT A PT WAS BURNED WHILE USING THE PRODUCT. ON (B)(6) 2012, RECEIVED ADDITIONAL INFO FROM THE USER FACILITY INDICATING THAT THE PT RECEIVED 3RD DEGREE BURNS AS A RESULT OF USING THE PRODUCT AND THEY NEEDED TO REFER THE PT TO THE EMERGENCY DEPARTMENT AT THE HOSPITAL FOR TREATMENT.
Additional Manufacturer Narrative
THE RETURNED DEVICE WAS EVALUATED BY DJO AND FOUND TO HAVE MET SPECIFICATIONS AND DID NOT MALFUNCTION.