MalfunctionJOS
PED RETURN ELEC
Received Nov 27, 2012 · Event occurred Oct 16, 2012
Report 1717344-2012-01144 · MDR key 2902040
Device
Generic name
Pediatric Patient Return Electrode
Manufacturer
Covidien LpCatalog number
E751025
Lot number
206253X
Product problems
- Device Operates Differently Than Expected
Patient
3 YR
- Burn(s)
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE PT WAS BURNED AT THE PAD SITE DURING AN ORTHOPEDIC PROCEDURE ON THE LOWER LEG. THE BURN WAS DETECTED 15 DAYS AFTER THE SURGERY AND TREATED WITH A DRESSING.
Additional Manufacturer Narrative
(B)(4). THE INCIDENT SAMPLE WAS DISCARDED BY THE SITE AND IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.