InjuryIPF
OMNISTIM ELECTROTHERAPY ELECTRODE
Received Feb 28, 2020 · Event occurred Feb 17, 2020
Report MW5093393 · MDR key 9774524
Device
Generic name
Stimulator, Muscle, Powered
Manufacturer
Accelerated Care PlusCatalog number
61227
Lot number
Y113018-01
Product problems
- Material Separation
Patient
55 YR
- Pain
- Burn, Thermal
- Pain
- Burn, Thermal
Narrative
Description of Event or Problem
DURING ELECTRICAL SLIM TREATMENT RESIDENT COMPLAINED OF PAIN AT ELECTRODE SITE. TREATMENT STOPPED, AREA INSPECTED. FOUND ELECTRODE WIRE HAD SEPARATED FROM GEL PAD. SKIN INSPECTED AND FOUND TO HAVE 1.5" INNER-SHAPED BURN TO THIGH. FDA SAFETY REPORT ID # (B)(4).