FDA Adverse Event
Other
Summary report: N
TAPERFLO
MDR report key: 3783528
·
Received April 15, 2014
Report
- Report Number
- 9612515-2014-00002
- Event Type
- Other
- Date Received
- April 15, 2014
- Date of Event
- March 17, 2014
- Report Date
- April 15, 2014
- Manufacturer
- VASCUTEK LTD.
- Product Code
- DSY
- PMA / PMN Number
- K092863
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). VASCUTEK IS NOT PRIVY TO ANY PT INFO .(B)(4). METHOD: DEVICE HAS BEEN RETURNED AND IS BEING EVALUATED. RESULT: EVALUATION OF DEVICE IN PROGRESS. CONCLUSION: EVALUATION NOT YET COMPLETE.
Description of Event or Problem · 1
THE EVENT WAS REPORTED TO VASCUTEK AS FOLLOWS: THE SURGEON REPORTED THAT, ALTHOUGH HE COULD NOT FIND THE EXACT LOCATIONS OF THE DEFECT WITH THE NAKED EYE, THERE WERE MORE THAN THREE LEAKAGES ON THE SURFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230840 | TAPERFLO | GELATIN SEALED EPTFE PROSTHESIS | DSY | VASCUTEK LTD. | TAPERFLO | 13116359 6110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |