MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-27 for CEFALY manufactured by Cefaly Technology.
[96054491]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074265 |
| MDR Report Key | 7150597 |
| Date Received | 2017-12-27 |
| Date of Report | 2017-12-12 |
| Date Added to Maude | 2017-12-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | CEFALY |
| Generic Name | STIMULATOR, NERVE, ELECTRICAL |
| Product Code | PCC |
| Date Received | 2017-12-27 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CEFALY TECHNOLOGY |
| Manufacturer Address | RUE LOUIS PLESCIA, 34 SERAING 4102 BE 4102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-27 |