PED RETURN ELEC
Received Mar 9, 2015 · Event occurred Feb 12, 2015
Report 1717344-2015-00181 · MDR key 4581152
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Burn, Thermal
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT FOLLOWING AN INGUINAL HERNIA PROCEDURE, A BURN MARK WAS NOTED AT THE RETURN PAD SITE ON A MALE INFANT,(B)(6), THE RETURN PAD HAD BEEN PLACED ON THE LOWER PART OF THE PATIENT'S BACK. THE DEGREE OF BURN WAS NOT KNOWN. THE AREA WAS BANDAGED. THERE WAS ALSO RESIDUE OF THE ANTISEPTIC YELLOW WASH SOLUTION AROUND THE AREA.
Additional Manufacturer Narrative
(B)(4). DATE OF INITIAL REPORT: 03/09/2015. THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.