MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-16 for CHATANOOGA VECTRA GENISYS 2761 manufactured by .
[4460930]
This is a pt who was undergoing a physical therapy treatment with a chattanooga tens unit. He sustained a possible 3rd degree burn about 10 x 6 mm on the right lower lumbar area, with dark grayish discoloration and a group of blisters represent 2nd degree burn around the area. The unit was turned up to the pt's tolerance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3874448 |
| MDR Report Key | 3874448 |
| Date Received | 2012-05-16 |
| Date of Report | 2014-05-09 |
| Date of Event | 2014-01-16 |
| Date Facility Aware | 2014-02-12 |
| Report Date | 2014-05-09 |
| Date Reported to FDA | 2014-05-09 |
| Date Added to Maude | 2014-06-17 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATANOOGA |
| Generic Name | TENS UNIT |
| Product Code | IMG |
| Date Received | 2012-05-16 |
| Model Number | VECTRA GENISYS 2761 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-16 |