FACEMASTER

Received May 11, 2006

Report MW4004179 · MDR key 723807

Device

Generic name

Facial Toning Device

Manufacturer

Model number

Catalog number

Lot number

Product problems

Energy Output To Patient Tissue Incorrect

Patient

Eye Injury
Vitreous Floaters
Headache
Tinnitus

Narrative

Description of Event or Problem

REPORTER STATES THAT THE REFERENCED DEVICE NEEDS CONSPICUOUS WARNINGS TO CHECK THE ELECTRICAL STIMULATION SETTING BEFORE EACH USE. SHE USED THE DEVICE AT THE WRONG SETTING AND SUFFERED A SEVERE MIGRAINE HEADACHE, VITREAL DETACHEMENT WITH HER EYES, DEVELOPED FLOATERS IN HER EYES & TINNITUS.