MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-21 for CEFALY ANTI-MIGRAINE DEVICE manufactured by Cefaly Technology.
[55608443]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064984 |
| MDR Report Key | 5973026 |
| Date Received | 2016-09-21 |
| Date of Report | 2015-09-21 |
| Date of Event | 2015-09-15 |
| Date Added to Maude | 2016-09-23 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 ANTI-MIGRAINE DEVICE |
| Generic Name | NERVE STIMULATOR FOR MIGRAINES |
| Product Code | PCC |
| Date Received | 2016-09-21 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CEFALY TECHNOLOGY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-21 |