FDA Adverse Event
Malfunction
Summary report: N
FORCETRIAD ENERGY PLATFORM
MDR report key: 3940448
·
Received April 17, 2014
Report
- Report Number
- 1717344-2014-00329
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- March 13, 2014
- Report Date
- March 19, 2014
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). TO DATE THE INCIDENT UNIT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE PT WAS BURNED WHILE USING THE DEVICE IN MONOPOLAR MODE. THE PT RECEIVED A 2ND DEGREE BURN AT THE LEVEL OF THE PATCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235943 | FORCETRIAD ENERGY PLATFORM | ELECTROSURGICAL GENERATOR | GEI | COVIDIEN LP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |