MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-28 for ELITE MASSAGER MONO ME1-140726-0870 4474567894086 manufactured by Elite Massager Llc.
[5320407]
During the use of the elite massager mono, i had a seizure. I was told by the man at the (b)(6), that it would not affect, but help to lessen my seizure disorder. When i had the seizure, i got on the internet to find that he wasn't approved by the fda as he had said, and that they are under investigation. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040554 |
| MDR Report Key | 4479473 |
| Date Received | 2015-01-28 |
| Date of Report | 2015-01-28 |
| Date of Event | 2015-01-27 |
| Date Added to Maude | 2015-02-04 |
| 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 | ELITE MASSAGER MONO |
| Generic Name | ELITE MASSAGER MONO |
| Product Code | ISA |
| Date Received | 2015-01-28 |
| Model Number | ME1-140726-0870 |
| Catalog Number | 4474567894086 |
| Lot Number | 4474567894086 |
| ID Number | 4474567894086 |
| Device Expiration Date | 2016-01-18 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELITE MASSAGER LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2015-01-28 |