MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-22 for SUZANNE SOMERS FACEMASTER manufactured by Facemaster.
[3454614]
I was using a suzanne somers facemaster, and it hit a nerve on my brow that caused great pain. It did not go away, and so i went to the doctor, and he said i had damaged my trigeminal nerve, and now had trigeminal neuralgia. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030294 |
| MDR Report Key | 3131176 |
| Date Received | 2013-05-22 |
| Date of Report | 2013-05-16 |
| Date of Event | 2013-01-13 |
| Date Added to Maude | 2013-05-29 |
| 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 | ATTORNEY |
| 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 | SUZANNE SOMERS FACEMASTER |
| Generic Name | FACIAL TONING SYSTEM |
| Product Code | NFO |
| Date Received | 2013-05-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FACEMASTER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-22 |