FDA Adverse Event
Other
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2428908
·
Received January 20, 2012
Report
- Report Number
- 3007069406-2012-00022
- Event Type
- Other
- Date Received
- January 20, 2012
- Report Date
- August 24, 2010
- Manufacturer
- PEAK SURGICAL, INC.
- Product Code
- GEI
- PMA / PMN Number
- K083415
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. MALE PT, 5 TO 8 YEARS OF AGE, HAD A POST-OP BLEED 6 DAYS AFTER SURGERY. BLEEDING CONTROLLED IN PHYSICIAN'S OFFICE WITH SILVER NITRATE.
Description of Event or Problem · 1
INITIAL EVENT DESCRIPTION: PT HAD POST-OP BLEED 6 DAYS AFTER SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE TISSUE DISSECTION DEVICE | GEI | PEAK SURGICAL, INC. | PLASMABLADE TNA | 28529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | NOT AVAILABLE |