DISPOSABLE GROUNDING PAD W/CABLE
Received Dec 5, 2020 · Event occurred Nov 6, 2020
Report 2182269-2020-00107 · MDR key 10951667
Device
Generic name
Disposable Grounding Pad
Manufacturer
St. Jude Medical, Inc.Model number
AFD0299Lot number
20190825
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem
FOLLOWING CERVICAL FACET RF ABLATION PROCEDURE, THE PATIENT EXPERIENCED A BURN AT THE GROUNDING PAD SITE. THIS PATIENT HAS ONE OTHER ABLATION PROCEDURE AT THE SAME SITE IN THE PAST. THE GROUNDING PAD WAS PLACED ON LEFT FLANK ON UNPREPPED DRY SKIN. FOLLOWING REMOVAL OF THE GROUNDING PAD THERE WAS A WHITE BLISTERED PATCH OF SKIN THE SIZE OF AN INCH. THE PATIENT WAS TREATED WITH ANTIBIOTIC OINTMENT AND IS IN STABLE CONDITION. IT WAS NOTED THAT NO ALARMS APPEARED ON THE GENERATOR AND THERE WERE NO SIGNS OF GENERATOR FAILURE.