FDA Adverse Event
Injury
Summary report: N
DISP PNCL W/HLSTR BULKPAK
MDR report key: 4266625
·
Received November 20, 2014
Report
- Report Number
- 1717344-2014-00985
- Event Type
- Injury
- Date Received
- November 20, 2014
- Report Date
- November 4, 2014
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. NO CONDITIONS WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN THE SURGEON STOPPED USING THE CAUTERY PENCIL, THE DEVICE ACTIVATED ON ITS OWN DURING A BREAST REDUCTION PROCEDURE. THE PATIENT RECEIVED A 3RD DEGREE BURN HIGH ON THE ABDOMEN. THE BURN REQUIRED DEBRIDEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 752214 | DISP PNCL W/HLSTR BULKPAK | ES ACCESSORY, NON-STERILE | GEI | COVIDIEN LP | E2515HGNSB | 41420158X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |