FDA Adverse Event
Malfunction
Summary report: N
VISISTAT 35R 6/BOX
MDR report key: 4163207
·
Received July 16, 2014
Report
- Report Number
- 3003898360-2014-00463
- Event Type
- Malfunction
- Date Received
- July 16, 2014
- Date of Event
- June 1, 2014
- Report Date
- June 20, 2014
- Manufacturer
- TELEFLEX
- Product Code
- GAG
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
COMPLAINT ALLEGES: IT WAS REPORTED THAT THE STAPLER GETS BLOCKED. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416955 | VISISTAT 35R 6/BOX | STAPLER | GAG | TELEFLEX | 01M1300167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |