PED RETURN ELEC
Received Nov 14, 2012
Report 1717344-2012-01162 · MDR key 2888581
Device
Generic name
Pediatric Patient Return Electrode
Manufacturer
Covidien LpCatalog number
E751025
Lot number
UNKNOWN
Product problems
- Improper Chemical Reaction
Patient
2 YR
- Burn(s)
- Reaction, Injection Site
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT AFTER BEING DISCHARGED A BURN LESION APPEARED ON THE PATIENT'S HIP. THE INJURY WAS DISCOVERED BY THE PATIENT'S PARENT. AN E7510 PATIENT RETURN ELECTRODE HAD BEEN IN USE DURING THE PROCEDURE AND HAD BEEN PLACED ON THE PATIENT'S CALF. NO PAD SITE INJURY WAS NOTED FOLLOWING THE PROCEDURE AND THE PAD WAS DISCARDED. THE LESION WAS REPORTED TO BE AT THE SITE WHERE SPINAL ANESTHESIA HAD BEEN ADMINISTERED. THE AREA HAD BEEN DISINFECTED WITH ANTISEPTIC SOLUTION OF CHLORHEXIDINE 2% AND ISOPROPANOL 70%. THE CAUSE OF THE INJURY IS UNKNOWN, BUT BELIEVED TO POSSIBLY BE RELATED TO THE ANTISEPTIC SOLUTION USED TO PREPARE THE ANESTHESIA SITE. INFORMATION REGARDING THE DEGREE OF INJURY AND TYPE OF TREATMENT WAS NOT AVAILABLE.
Additional Manufacturer Narrative
(B)(4). THE INCIDENT RETURN PAD 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.