FDA Adverse Event
Injury
Summary report: N
CONMED SUREFIT® DISPERSIVE ELECTRODE
MDR report key: 1970764
·
Received January 25, 2011
Report
- Report Number
- 1720159-2011-00007
- Event Type
- Injury
- Date Received
- January 25, 2011
- Date of Event
- November 25, 2010
- Report Date
- December 16, 2010
- Manufacturer
- CONMED ELECTROSURGERY
- Product Code
- GEI
- PMA / PMN Number
- K100047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DISTRIBUTOR HAS BEEN REQUESTED TO PROVIDE CONMED WITH A MORE DETAILED DESCRIPTION OF THE REPORTED EVENT.A FOLLOW-UP MEDICAL DEVICE REPORT WILL BE SUBMITTED ONCE THE EVALUATION OF THE SUSPECT DEVICE IS COMPLETED.
Description of Event or Problem · 1
PATIENT'S SKIN WAS PEELED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED SUREFIT® DISPERSIVE ELECTRODE | ELECTROSURTGICAL DISPERSIVE ELECTRODE | GEI | CONMED ELECTROSURGERY | UNAVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |