MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-01-02 for UNKNOWN manufactured by Chattanooga Group.
[998123]
Patient was being treated in lumbar region by a physician and received a burn. The patient stopped the treatment because of the pain. No further information regarding patient status is available.
Patient Sequence No: 1, Text Type: D, B5
[8204602]
Device was not identified or returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00337 |
| MDR Report Key | 1280505 |
| Report Source | 06 |
| Date Received | 2009-01-02 |
| Date of Report | 2006-12-11 |
| Date Mfgr Received | 2006-12-11 |
| Date Added to Maude | 2009-01-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS ROAD |
| 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 | UNKNOWN |
| Generic Name | NONE |
| Product Code | IMJ |
| Date Received | 2009-01-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | 4717 ADAMS ROAD HIXSON TN 37343 US 37343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-01-02 |