FDA Adverse Event
Injury
Summary report: N
INTELECT XT 2CH COMBO PKG
MDR report key: 3127051
·
Received October 15, 2008
Report
- Report Number
- 1022819-2008-00392
- Event Type
- Injury
- Date Received
- October 15, 2008
- Manufacturer
- CHATTANOOGA GROUP
- Product Code
- IPF
- PMA / PMN Number
- K031077
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDER EVAL. THE DEVICE EVAL AND ANY ADD'L FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVAL. REF REPORT: 1022819-2008-00285, 00393.
Description of Event or Problem · 1
PT B WAS BURNED IN (B)(6) 2007. THE PT WAS (B)(6). THE CLIENT DID NOT REMEMBER THE DETAILS OF EACH TREATMENT BUT KNOWS THAT THESE BURNS OCCUR WHEN USING PREMOD OR RUSSIAN WAVEFORMS AND NO OTHERS. THE DEVICE, LEADWIRE, CURRENT ELECTRODES AND A SAMPLE OF THE SAME KIND OF ELECTRODES USED ON B WILL BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELECT XT 2CH COMBO PKG | IPF, IMG, GZJ, GZI | IPF | CHATTANOOGA GROUP | 2760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Required Intervention |