FDA Adverse Event
Other
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2573835
·
Received May 9, 2012
Report
- Report Number
- 3007069406-2012-00097
- Event Type
- Other
- Date Received
- May 9, 2012
- Date of Event
- September 7, 2011
- Report Date
- April 12, 2012
- Manufacturer
- MEDTRONIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K083415
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS NOT AVAILABLE FOR EVALUATION BECAUSE THE COMPLAINT FILE WAS OPENED BASED ON THE REVIEW OF THE CLINICAL STUDY FILE. A REVIEW OF THE LHR DID NOT REVEAL ANY ISSUES DURING THE MANUFACTURING OF THIS LOT. END OF REPORT.
Description of Event or Problem · 1
PATIENT PARTICIPATING IN TONSILLECTOMY STUDY RECEIVED A TONSILLECTOMY ON (B)(6) 2011. ON (B)(6) 2011, PATIENT REPORTED NAUSEA AND VOMITING AND WAS PRESCRIBED ZOFRAN (INTERVENTION) FOR RELIEF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE TISSUE DISSECTION DEVICE | GEI | MEDTRONIC ADVANCED ENERGY LLC | PLASMABLADE TNA | 35252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | NOT AVAILABLE |