FDA Adverse Event
Malfunction
Summary report: N
WECK VISISTAT 35R 6/BOX
MDR report key: 3021013
·
Received March 20, 2013
Report
- Report Number
- 3003898360-2013-00109
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- February 1, 2013
- Report Date
- March 6, 2013
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GDT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SAMPLE NOT RETURNED TO MFR IN TIME FOR THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT DESCRIPTION - THE STAPLER JAMMED DURING USE. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115804 | WECK VISISTAT 35R 6/BOX | SKIN STAPLER | GDT | TELEFLEX MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |