FDA Adverse Event
Other
Summary report: N
INVISATRACE
MDR report key: 499522
·
Received November 21, 2003
Report
- Report Number
- 1317214-2003-00059
- Event Type
- Other
- Date Received
- November 21, 2003
- Report Date
- October 21, 2003
- Manufacturer
- CONMED CORP
- Product Code
- DRX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
"IT WAS REPORTED THAT" PT WHO HAS RETARDATION, WAS SEDATED FOR A LUMBAR SPINE. ANESTHESIA WAS USED AND ELECTRODES WERE PLACED UNDER THE BREAST. BURNS OCCURRED AND WERE BILATERAL. MORE POWER WAS USED IN THE MRI DURING THIS PROCEDURE.
Description of Event or Problem · 2
ANOTHER PT WAS WEARING THE ELECTRODE UNDER THE BREAST AREA AND WAS SEDATED AS WELL. THESE WERE WORN DURING AN MRI W/DATA SCOPE MONITORING.
Description of Event or Problem · 3
THE THIRD PT HAD MARKS IN THE SHAPE OF THE ADHESION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVISATRACE | ECG MONITORING ELECTRODE | DRX | CONMED CORP | NA | 0209261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | SILVADEEN AND NEOSPORAN. | |
| 2 | UNKNOWN | Other | SILVADEEN AND NEOSPORAN | |
| 3 | UNKNOWN | Other | SILVADEEN AND NEOSPORAN |