FDA Adverse Event
Other
Summary report: N
3 X 3 DUREPAIR DURA SUBSTITUTE
MDR report key: 1375583
·
Received February 25, 2009
Report
- Report Number
- 2021898-2009-00040
- Event Type
- Other
- Date Received
- February 25, 2009
- Report Date
- January 29, 2009
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- GXQ
- PMA / PMN Number
- K041000
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION POST-NEUROSURGERY. DUREPAIR WAS USED IN THE PATIENT'S SURGERY AND MAY POSSIBLY BE RELATED TO THE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3 X 3 DUREPAIR DURA SUBSTITUTE | GXQ | MEDTRONIC NEUROSURGERY | NA | 0809021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O |