MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-21 for LEGEND XT 4 CH COMBO 2788 manufactured by Chattanooga Group.
[19462339]
Clinician conducted electrotherapy treatment on the pt's neck area when the pt began complaining of pain in the area of treatment. The clinician stopped the treatment. The pt suffered a 2nd to 3rd degree burn, 1 cm in diameter, in the treatment area of the electrodes. The pt did not require any immediate or known post medical treatment for the burns. The patient has rec'd electrotherapy treatment prior to this incident. The clinician treated the pt using 4 pole interferential treatment (ifc). The treatment time was set for 12-15 minutes. The remaining treatment parameters, constant voltage/constant current, carrier frequency and intensity could not be provided by the attending clinician. The electrodes were previously used on the pt. The clinician started the electrotherapy; the pt was not holding the pt switch. After an undetermined amount of time, the pt became distressed during the treatment and called for assistance. The clinician returned to the pt and stopped the treatment. The clinician did not indicate any changes in the treatment settings. The electrodes were removed from the treatment area and burns were noted. The burns occurred under the electrodes.
Patient Sequence No: 1, Text Type: D, B5
[19709122]
Awaiting return and evaluation of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00044 |
| MDR Report Key | 1006100 |
| Report Source | 05 |
| Date Received | 2008-02-21 |
| Date of Report | 2008-02-14 |
| Date of Event | 2007-06-01 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2008-05-01 |
| 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 | 0 |
| 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 | LEGEND XT 4 CH COMBO |
| Generic Name | POWER MUSCLE STIMULATOR |
| Product Code | LIH |
| Date Received | 2008-02-21 |
| Model Number | 2788 |
| Catalog Number | 2788 |
| 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 | 1002830 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-02-21 |