MalfunctionPCC
CEFALY
Received Feb 4, 2020 · Event occurred Nov 27, 2019
Report MW5092757 · MDR key 9671457
Device
Generic name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Manufacturer
Cefaly TechnologyProduct problems
- Product Quality Problem
Patient
59 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
UNABLE TO TREAT MIGRAINE; I PURCHASE THE CEFALY IN 2018. IT FELL APART IN 2019 RENDERING IT INOPERABLE TO PROVIDE RELIEF FOR MY MIGRAINES. THE PRODUCT IS EXPENSIVE, (B)(6). THE PRODUCT SHOULD NOT FALL APART AFTER NORMAL USE. FDA SAFETY REPORT ID# (B)(4).