InjuryEGJ
HYBRESIS
Received Sep 27, 2012 · Event occurred Sep 25, 2009
Report 1721293-2012-00004 · MDR key 2762477
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Burn(s)
Narrative
Description of Event or Problem
IT WAS REPORTED TO EMPI ON (B)(6) 2012, THAT A PATIENT WAS ALLEGEDLY BURNED WITH A HYBRESIS PATCH ON (B)(6) 2009.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EMPI TO EVALUATE. THIS INCIDENT IS SIMILAR TO A COMPLAINT RECEIVED BY EMPI THAT SUGGESTS THAT THIS DEVICE MAY HAVE MALFUNCTIONED IN SUCH A WAY THAT IT COULD HAVE CONTRIBUTED TO THIS INJURY. DEVICE NOT RETURNED.