FDA Adverse Event
Malfunction
Summary report: N
HT APPLIER MED 6' CVD
MDR report key: 2900884
·
Received December 12, 2012
Report
- Report Number
- 1044475-2012-00164
- Event Type
- Malfunction
- Date Received
- December 12, 2012
- Date of Event
- November 29, 2012
- Report Date
- November 29, 2012
- Manufacturer
- TELEFLEX
- Product Code
- FZP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: ALLEGED ISSUE: DURING INCOMING INSPECTION OF DEVICE, THE DOCTOR SAID ON A VIDEO HE PROVIDED THAT WHEN THE APPLIER CLOSES THE CLIP, THE ENDS DON'T MEET PROPERLY. NO PT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HT APPLIER MED 6' CVD | APPLIER | FZP | TELEFLEX | 06B1141116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |