MalfunctionPCC
CEFALY
Received Dec 27, 2017
Report MW5074265 · MDR key 7150597
Device
Generic name
Stimulator, Nerve, Electrical
Manufacturer
Cefaly TechnologyProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
58 YR
- Reaction
- Reaction
Narrative
Description of Event or Problem
REPORTS USE OF CEFALY DEVICE WITH GOOD RESULT FOR SEVERAL MONTHS, BUT THEN DEVELOPED SKIN REACTION ACROSS FOREHEAD FROM ELECTRODE GEL. RESOLVED WITH TRIAMCINOLONE RX BY DERM. RECURRENCE WITH USE, DESPITE HYPOALLERGENIC GEL. DATES OF USE: (B)(6) 2017. (B)(4).