FDA Adverse Event
Other
Summary report: N
LEGEND XT 4CH COMBO
MDR report key: 1016326
·
Received March 21, 2008
Report
- Report Number
- 1022819-2008-00098
- Event Type
- Other
- Date Received
- March 21, 2008
- Date of Event
- March 10, 2008
- Report Date
- March 17, 2008
- Manufacturer
- CHATTANOOGA GROUP
- Product Code
- GZJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AWAITING RETURN AND EVALUATION OF THE DEVICE. IPF, STIMULATOR, MUSCLE, POWERED,(B)(4); GZI, STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL, (B)(4).
Description of Event or Problem · 1
PATIENT RECEIVED AN INFERENTIAL CURRENT ELECTROTHERAPY TREATMENT. THE PATIENT LATER REPORTED A BURN IN THE TREATMENT AREA. THE BURN WAS REPORTED TO BE IN THE PROXIMITY OF THE ELECTRODE PLACEMENT DURING THE PREVIOUS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEGEND XT 4CH COMBO | GZJ, STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF, 882.5810 | GZJ | CHATTANOOGA GROUP | 2788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |