MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-22 for INTELECT LEGEND STIM INT002 manufactured by Chattanooga Group.
[795795]
Clinician conducted an electrotherapy treatment on the pt's right shoulder area. The electrotherapy treatment was performed in conjunction with a heat therapy. The heat therapy device and manufacture is noted as thermafor. The burn was noted upon completion of treatment. The pt suffered one - 3rd degree burn, diameters of burn(s) is estimated at 1cm, in the treatment area of the electrodes. The clinician did not know if the pt sought post medical treatment for the burn(s). The pt had received electrotherapy treatments (6) prior to this incident. The clinician treated the pt using 4 pole interferential treatments (ifc). The settings are default constant voltage settings. The treatment session intensity is 'increased to tolerance. ' the treatment symptom is lower back pain. The treatment time was set for 12 minutes. The clinician could not determine the condition of the electrodes. The pt was not holding the pt switch. Are you aware of any other pt incidents with this equipment or other chattanooga group equipment that might be in operation at your location?
Patient Sequence No: 1, Text Type: D, B5
[8091266]
Awaiting return and eval of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00052 |
| MDR Report Key | 1002358 |
| Report Source | 05 |
| Date Received | 2008-02-22 |
| Date of Report | 2008-02-18 |
| Date of Event | 2008-01-31 |
| Date Mfgr Received | 2008-02-11 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2008-02-27 |
| 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 | INTELECT LEGEND STIM |
| Generic Name | POWER MUSCLE STIMULATOR |
| Product Code | LIH |
| Date Received | 2008-02-22 |
| Returned To Mfg | 2008-02-11 |
| Model Number | INT002 |
| Catalog Number | INT002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 970744 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-02-22 |