FDA Adverse Event
Malfunction
Summary report: N
WECK VISISTAT FIXED HEAD SKIN STAPLERS
MDR report key: 2102966
·
Received May 11, 2011
Report
- Report Number
- 3003898360-2011-00239
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 18, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GDW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SAMPLE RECEIVED BY MFR, BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: ALLEGED ISSUE: TWO OF THE STAPLERS JAMMED DURING A SPAY/NEUTER PROCEDURE. THE ANIMAL WAS NOT HARMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WECK VISISTAT FIXED HEAD SKIN STAPLERS | SKIN STAPLER | GDW | TELEFLEX MEDICAL | 01C1000227 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |