MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for FASCIABLASTER manufactured by Ashley Black.
[87481065]
I started using the fascia blaster the last week of (b)(6) 2016. About a week later i had a lot of fatigue and flu like symptoms. By the end of (b)(6) i had gained 10 and my thyroid medication had to be upped. In (b)(6) i received the faceblaster and by (b)(6) my skin felt like it was on fire all the time. It was very painful. It still happens but rarely. I stopped using the blasters soon afterwards.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072425 |
| MDR Report Key | 6893979 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-24 |
| Date of Event | 2016-09-07 |
| Date Added to Maude | 2017-09-26 |
| 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 | FASCIABLASTER |
| Generic Name | FASCIABLASTER |
| Product Code | IOD |
| Date Received | 2017-09-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-09-25 |