FDA Adverse Event
Death
Summary report: N
MIIG X3 MINIMALLY INVASIVE INJECTABLE GRAFT
MDR report key: 874150
·
Received June 29, 2007
Report
- Report Number
- 1043534-2007-00091
- Event Type
- Death
- Date Received
- June 29, 2007
- Report Date
- June 11, 2007
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- MQV
- PMA / PMN Number
- K024336
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETED. ADD'L INFO HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETED. THIS EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
ALLEGEDLY, PT DIED ON THE SURGICAL TABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIIG X3 MINIMALLY INVASIVE INJECTABLE GRAFT | MQV | WRIGHT MEDICAL TECHNOLOGY, INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |