MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-01-21 for VECTRA GENISYS 2789 manufactured by Chattanooga Group.
[806176]
They were treating a patient with early signs of dementia. They kept increasing intensity and patient received a burn. They were using interferential not sure what ch or what level of intensity. Received burn to back. They are returning leads and pads.
Patient Sequence No: 1, Text Type: D, B5
[8087246]
Awaiting return of unit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00027 |
| MDR Report Key | 984220 |
| Report Source | 08 |
| Date Received | 2008-01-21 |
| Date of Report | 2008-01-17 |
| Date of Event | 2007-12-19 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2008-04-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VECTRA GENISYS |
| Generic Name | POWER MUSCLE STIMULATOR |
| Product Code | LIH |
| Date Received | 2008-01-21 |
| Model Number | 2789 |
| Catalog Number | 2789 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 986561 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-21 |