MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-24 for CEFALY II manufactured by Cefaly Technology.
[76148009]
On (b)(6) 2017, day one - i received the device and charged it. The next day, day two on (b)(6) 2017, i used it for the recommended 20 minutes reducing the intensity. The following day - day 3 on (b)(6) 2017, i used it for the recommended 20 minutes. The ringing in my ears increased. It has not gone away, was a low volume. Now it is a medium volume.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070032 |
| MDR Report Key | 6593589 |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-04-14 |
| Date Added to Maude | 2017-05-26 |
| 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 | 0 |
| Brand Name | CEFALY II |
| Generic Name | STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS FOR MIGRAINE |
| Product Code | PCC |
| Date Received | 2017-05-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CEFALY TECHNOLOGY |
| Manufacturer Address | BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-24 |