FDA Adverse Event
Injury
Summary report: N
PLASMABLADE 3.0 WIDE SPATULA
MDR report key: 2994679
·
Received March 8, 2013
Report
- Report Number
- 1226420-2013-00049
- Event Type
- Injury
- Date Received
- March 8, 2013
- Date of Event
- January 2, 2013
- Report Date
- March 8, 2013
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- DWG
- PMA / PMN Number
- K093695
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT # (B)(4). METHOD: PRODUCT NOT BEING RETURNED TO MANUFACTURER FOR ANALYSIS. METHOD: PRODUCT NOT BEING RETURNED TO MANUFACTURER FOR ANALYSIS. METHOD: PRODUCT NOT BEING RETURNED TO MANUFACTURER FOR ANALYSIS. (B)(4).
Description of Event or Problem · 1
SURGEON SAID HE HAD POST-OP FLAP NECROSIS ON LARGER BREASTED WOMEN WITH THE USE OF PLASMABLADE THAT HE NEVER HAD WITH A BOVIE. SURGEON STOPPED USING THE PB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 99827 | PLASMABLADE 3.0 WIDE SPATULA | ELECTROSURGICAL DEVICE | DWG | MEDTRONIC ADVANCED ENERGY, LLC | PS210-030S | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |