MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-07 for SONIC COMFORT manufactured by Innovate, Llc.
[40059789]
Husband suffered skin burns on his back. Home/apartment/condominium - (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060792 |
| MDR Report Key | 5489896 |
| Date Received | 2016-03-07 |
| Date of Report | 2016-02-25 |
| Date of Event | 2016-02-25 |
| Date Added to Maude | 2016-03-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | SONIC COMFORT |
| Generic Name | PERSONAL MASSAGER WITH HEAT THERAPY |
| Product Code | ISA |
| Date Received | 2016-03-07 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | INNOVATE, LLC |
| Manufacturer Address | PLANO TX 75024 US 75024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-07 |