MalfunctionGZI

CHATANOOGA GROUP E-STIM VECTRA GENISYS

Received Apr 7, 2025 · Event occurred Mar 15, 2025

Report MW5168659 · MDR key 21786330

Device

Generic name

Stimulator, Neuromuscular, External Functional

Manufacturer

Djo, Llc

Lot number

24L129

Product problems

Patient Device Interaction Problem
Excessive Heating

Patient

59 YR · Male

Erythema
Blister
Erythema
Blister

Narrative

Description of Event or Problem

FOLLOWING E-STIM/MHP (ELECTRICAL STIMULATION/MOIST HEAT PACK), THE PATIENT'S SKIN WAS ASSESSED WHICH REVEALED INCREASED REDNESS WHERE THE E-STIM PADS HAD BEEN PLACED. THE PATIENT FOLLOWED UP WITH PROVIDER AND SKIN BLISTERED AND WILL REQUIRE WOUND TREATMENT.