MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-14 for LEGEND 2C * manufactured by Djo, Llc.
[2768445]
Pt was in physical therapy and hooked up to a (b)(4) legend 2c with the serial number of (b)(4). Pt skin integrity and electrodes were checked prior to procedure and were intact. Pt was on interferential current (preset) and was ramped up to an intensity of 30. At just under 5' the pt started to complain of a burning sensation. The electrodes were removed and a small, white dimpled area was on pt's skin. Nursing was notified as well as the md. Burn cream was ordered by the physician. Dates of use: (b)(6) 2011 - (b)(6) 2012. Reason for use: physical therapy modality typically used to treat pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025845 |
| MDR Report Key | 2622836 |
| Date Received | 2012-06-14 |
| Date of Report | 2012-06-14 |
| Date of Event | 2012-06-06 |
| Date Added to Maude | 2012-06-21 |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEGEND 2C |
| Generic Name | ESTIM |
| Product Code | IMG |
| Date Received | 2012-06-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 2782 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION ST VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-14 |