MalfunctionEGJ
ACTION PATCH ELECTRODE
Received Dec 11, 2010 · Event occurred Nov 5, 2010
Report 1721293-2010-00018 · MDR key 1931903
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Burn, Thermal
Narrative
Description of Event or Problem
IT WAS REPORTED TO EMPI THAT A PATIENT WAS BURNED USING OUR ACTION PATCH DEVICE. REASONABLE ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION FROM THE USER FACILITY; HOWEVER, NONE WAS PROVIDED.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED AND AN EVALUATION WAS PERFORMED. THE DEVICE DID NOT MEET PHYSICAL SPECIFICATIONS DUE TO THE KARAYA GEL MISSING. THE PATCH WAS ALSO USED PAST THE EXPIRATION DATE OF AUGUST 2010. IF THE ACTION PATCH WAS USED WITHOUT KARAYA GEL THIS COULD CAUSE A BURN. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.