MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-24 for CEFALY manufactured by Cefaly Technology.
[5036585]
I purchased a cefaly medical device prescribed by my neurologist to help decrease the frequency of the headaches which i have suffered with for many years. U. S. Patent # 8,428,734.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038794 |
| MDR Report Key | 4201657 |
| Date Received | 2014-10-24 |
| Date of Report | 2014-10-11 |
| Date of Event | 2014-08-01 |
| Date Added to Maude | 2014-10-28 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEFALY |
| Generic Name | CEFALY |
| Product Code | PCC |
| Date Received | 2014-10-24 |
| Lot Number | 6SB45 14073 D4.23 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CEFALY TECHNOLOGY |
| Manufacturer Address | HERSTAL BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-24 |