MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-11 for LEGEND XT 4CH 7550 manufactured by Chattanooga Group.
[1924674]
Unit reported to have shocked/burned two patients, more recent on male patient upper shoulder, caused deep burn. The patient injured is a (b)(6) male, (b)(6), treated for post right shoulder surgery trapezius pain. The date of treatment is (b)(6) 2010. The preset protocol for the ifc wave form with constant current was used. Dura-stick 2 x 2 inches pads were applied on the treatment area. No preparation was performed prior to treatment. The second degree burn was found at a later date under one electrode placement site. The electrode pads were stored in the sealed plastic bag. Moist heat was also used during the electrotherapy. The patient sought further medical treatment and the injury was managed by a md.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022819-2011-00004 |
| MDR Report Key | 2018860 |
| Report Source | 06 |
| Date Received | 2011-03-11 |
| Date of Report | 2011-03-11 |
| Date of Event | 2010-12-10 |
| Date Mfgr Received | 2011-03-08 |
| Date Added to Maude | 2011-03-18 |
| 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 Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607343047 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEGEND XT 4CH |
| Generic Name | NA |
| Product Code | IMI |
| Date Received | 2011-03-11 |
| Returned To Mfg | 2011-01-10 |
| Model Number | 7550 |
| Catalog Number | 7550 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | 4717 ADAMS RD. HIXSON TN 37343 US 37343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-11 |