inforMED
MalfunctionJOS

PED RETURN ELEC

Received Dec 7, 2015

Report 1717344-2015-00877 · MDR key 5270371

Device

Generic name

Patient Grounding Pad

Manufacturer

Covidien Lp

Model number

E751025

Catalog number

E751025

Product problems

  • Overheating of Device

Patient

Not reported

  • Burn(s)

Narrative

Additional Manufacturer Narrative

(B)(4). THE INCIDENT GROUNDING PAD WAS DISCARDED BY THE USER AND IS NOT AVAILABLE FOR EVALUATION.

Description of Event or Problem

THE CUSTOMER REPORTED THE REM PAD WAS USED DURING SPINAL SURGERY ON A 15-20 LB MALE DOG. THE PAD HAD BEEN PLACED ON THE DOG'S ABDOMEN. UPON REMOVAL, A LITTLE REDNESS WAS NOTICED. IT WAS IDENTIFIED AS SKIN SENSITIVITY. THE PATIENT WAS DISCHARGED HOME WITH OWNER. THE OWNER RETURNED 10 DAYS LATER BECAUSE THE DOG WAS BURNED IN THE SHAPE OF THE REM PAD. THE WOUND WAS TREATED WITH ANTIBACTERIAL OINTMENT. THE VET REPORTED THE INJURY WAS A BURN.