MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-05-05 for VECTRA GENISYS 2 CHANNEL COMBO PKG. 2761 manufactured by Chattanooga Group.
[765368]
Three pts burned after receiving muscle stimulation in ifc mode. One pt received medical care. The treating physician diagnosed third degree burns.
Patient Sequence No: 1, Text Type: D, B5
[8088121]
Conclusion: device returned and investigation by manufacturers engineering department. The device functioned properly. Mechanical damage to the accessory lead wires was discovered in the investigation. Clinical text books tech practitioners to check electrotherapy lead wires for wear before each treatment. See scanned page.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2006-00005 |
| MDR Report Key | 967369 |
| Report Source | 06 |
| Date Received | 2006-05-05 |
| Date of Report | 2006-04-27 |
| Date of Event | 2006-03-29 |
| Date Facility Aware | 2006-03-10 |
| Report Date | 2006-03-29 |
| Date Reported to FDA | 2006-04-27 |
| Date Mfgr Received | 2006-03-29 |
| Date Added to Maude | 2008-04-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238707207 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VECTRA GENISYS 2 CHANNEL COMBO PKG. |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | LIH |
| Date Received | 2006-05-05 |
| Returned To Mfg | 2006-04-05 |
| Model Number | 2761 |
| Catalog Number | 2761 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 972766 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | 4717 ADAMS RD. HIXSON TN 37343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-05-05 |