CEFALY ANTI-MIGRAINE DEVICE
Received Sep 21, 2016 · Event occurred Sep 15, 2015
Report MW5064984 · MDR key 5973026
Device
Generic name
Nerve Stimulator For Migraines
Manufacturer
Cefaly TechnologyProduct problems
- Device Operates Differently Than Expected
Patient
65 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
UPON UTILIZATION OF CEFALY DEVICE FOR MIGRAINES, PATIENT STATES THAT TINNITUS ENSUED AND HAS CONTINUED 1 YEAR POST USE. PATIENT ALSO INDICATED THAT THE CHARACTER OF HER TINNITUS (NOISE) CURRENTLY EXPERIENCED POST USE IS THE SAME AS THE CHARACTER (NOISE) HEARD DURING USE OF THE DEVICE. IN (B)(6) 2015, PATIENT CONTACTED THE MANUFACTURER AND WAS IGNORED. SHE STATES THAT THEY WERE UNWILLING TO DISCUSS UNLISTED SIDE EFFECTS FOR THIS DEVICE. PATIENT STATES THAT THERE IS NO CURE FOR HER INJURY AND HER MAJOR CONCERN IS THAT SIDE EFFECTS FOR THIS DEVICE IS NOT ACCURATELY LISTED TO INFORM THE CONSUMER.