FDA Adverse Event
Other
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2428907
·
Received January 20, 2012
Report
- Report Number
- 3007069406-2012-00019
- Event Type
- Other
- Date Received
- January 20, 2012
- Report Date
- November 4, 2010
- Manufacturer
- PEAK SURGICAL, INC.
- Product Code
- GEI
- PMA / PMN Number
- K083415
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) 2012: THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MFR. THE FACILITY DID NOT RETAIN THE DEVICE FOR EVAL, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. INVESTIGATION OF THE LOT HISTORY RECORD DID NOT NOTE ANY ISSUES DURING THE MFG OF THIS LOT. THE SALES REP REPORTED THAT A CHILD HAD A POST-OP BLEED AT 6 DAYS. PHYSICIAN FEELS THAT POPCORN THE CHILD ATE MAY HAVE BEEN THE CULPRIT.
Description of Event or Problem · 1
INITIAL EVENT DESCRIPTION: CHILD HAD POST-OP BLEED AT 6 DAYS POST SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE TISSUE DISSECTION DEVICE | GEI | PEAK SURGICAL, INC. | PLASMABLADE TNA | 30442 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | NOT AVAILABLE |