InjuryGEI

COVIDIEN VALLEYLAB

Received Jan 18, 2012 · Event occurred Nov 23, 2011

Report MW5023894 · MDR key 2426000

Device

Generic name

Valleylab Rem Patient Return Electroded

Manufacturer

Covidien

Model number

VALLEYLAB

Catalog number

E7507

Product problems

Device Operates Differently Than Expected

Patient

66 YR

Atrial Fibrillation
Full thickness (Third Degree) Burn

Narrative

Description of Event or Problem

NOTED THAT PT HAD QUARTER SIZE BURN WITH WHITISH/YELLOWISH SKIN EXPOSED, THEN 4 CM BY 3 CM BLISTER NOTED WITH SITE REDDENED AND WEEPING WHEN MAPPING PATCHES AND GROUNDING PAD REMOVED FOLLOWING ATRIAL FIB ABLATION.