MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for CEFALY manufactured by Cefaly Technology.
[178025743]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092757 |
| MDR Report Key | 9671457 |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-11-27 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEFALY |
| Generic Name | STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE |
| Product Code | PCC |
| Date Received | 2020-02-04 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CEFALY TECHNOLOGY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-04 |