MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-04 for TENS UNIT manufactured by Pain Management Technologies.
[56797531]
Pt reported a burn caused by a tens unit for use by the pt with the help of private care giver. This event was not reported to the (b)(4) until 09/28/2016 due to f/u by contact care provider. Burns were not noticeable by the time they were reported to the (b)(4). Item was removed from use. Therapy start date: (b)(6) 2016. Therapy end date: (b)(6) 2016. Diagnosis or reason for use: back pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065207 |
| MDR Report Key | 6002767 |
| Date Received | 2016-10-04 |
| Date of Report | 2016-10-03 |
| Date of Event | 2016-07-27 |
| Date Added to Maude | 2016-10-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | TENS UNIT |
| Generic Name | TENS UNIT |
| Product Code | NUH |
| Date Received | 2016-10-04 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PAIN MANAGEMENT TECHNOLOGIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-04 |