FDA Adverse Event
Death
Summary report: N
FORCETRIAD ENERGY PLATFORM
MDR report key: 3779683
·
Received April 25, 2014
Report
- Report Number
- 1717344-2014-00312
- Event Type
- Death
- Date Received
- April 25, 2014
- Date of Event
- March 31, 2014
- Report Date
- April 10, 2014
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT UNIT HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE COTTON DRESSINGS UNDER THE PATIENT STARTED TO BURN DURING SURGERY DUE TO LEAKING OF DISINFECTANT (SKINSEPT G). THE PROCEDURE WAS A NECROSECTOMY OF THE STUB. NEW INFORMATION (B)(6) 2014: THE BURN WAS A SECOND DEGREE ON THE RIGHT LOWER OF THE STUB, SIZE OF LESION APPROX. 5X3CM. BURN WAS NOT TREATED, AS THE PATIENT DIED AS A CONSEQUENCE OF VERY BAD CONDITIONS. DATE OF DEATH (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252314 | FORCETRIAD ENERGY PLATFORM | ELECTROSURGICAL GENERATOR | GEI | COVIDIEN LP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Death | E2100 REUSABLE PENCILW/15FT CORD 50U: LOT #210933X| HRA5 UNIVERSAL RETURN ELECTRODE X50: LOT #4008X| E0560 CLAMP/CORD ASSEMBLY: LOT #UNK |