FDA Adverse Event
Other
Summary report: N
DURAGEN PLUS DURAL REGENERATION MATRIX 3X3 1 PA
MDR report key: 1648150
·
Received March 31, 2010
Report
- Report Number
- 1121308-2010-00008
- Event Type
- Other
- Date Received
- March 31, 2010
- Date of Event
- March 18, 2010
- Report Date
- March 31, 2010
- Product Code
- GXQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTING FACILITY DESCRIBED AN EVENT INVOLVING A PT. THE SURGEON PLACED ONE PIECE OF DURAGEN-(B)(4) OVER CRANIECTOMY SITE. THE PT EXPERIENCED AN INFLAMMATORY REACTION FIVE WEEKS POST OPERATIVELY. THE DURAGEN WAS REMOVED. MICROBIAL CULTURES WERE OBTAINED AND NEGATIVE. PT WAS DISCHARGED ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURAGEN PLUS DURAL REGENERATION MATRIX 3X3 1 PA | NA | GXQ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |