MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-05 for EMPI manufactured by Empi.
[2206334]
Pt suffered a burn on her leg after empi hybresis patch was applied and controller turned on.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021652 |
| MDR Report Key | 2201938 |
| Date Received | 2011-08-05 |
| Date of Report | 2011-08-05 |
| Date of Event | 2010-09-27 |
| Date Added to Maude | 2011-08-16 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| 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 | EMPI |
| Generic Name | EMPI HYBRESIS PATCH |
| Product Code | EGJ |
| Date Received | 2011-08-05 |
| Returned To Mfg | 2010-10-11 |
| Lot Number | 82840 |
| ID Number | PART #199589-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMPI |
| Manufacturer Address | 205 HWY 22 EAST PO BOX 709 CLEAR LAKE SD 57226 US 57226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-05 |