FDA Adverse Event
Injury
Summary report: N
STOCKERT RF GENERATOR
MDR report key: 1202998
·
Received October 17, 2008
Report
- Report Number
- 9612355-2008-00020
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- September 19, 2008
- Report Date
- September 22, 2008
- Manufacturer
- STOCKERT GMBH
- Product Code
- DRF
- PMA / PMN Number
- P990071
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INDIFFERENT ELECTRODE (3M) WAS REMOVED AFTER AN ABLATION, AND THERE WAS A BURN ON THE PATIENT'S BACK, WHERE THE PATCH HAD BEEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STOCKERT RF GENERATOR | RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE | DRF | STOCKERT GMBH | 39D-76X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | 3M INDIFFERENT ELECTRODE |