FDA Adverse Event
Other
Summary report: N
BIOGLUE SURGICAL ADHESIVE
MDR report key: 1220578
·
Received October 30, 2008
Report
- Report Number
- 1063481-2008-00025
- Event Type
- Other
- Date Received
- October 30, 2008
- Report Date
- October 30, 2008
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MFI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
Description of Event or Problem · 1
ACCORDING TO THE REPORT, BIOGLUE WAS USED DURING A NEUROSURGICAL PROCEDURE IN CONJUNCTION WITH SYNTHETIC DURA WHERE A LOT OF CSF FLUID WAS LEAKING AND THE FILED COULD NOT BE KEPT DRY. SUBSEQUENTLY, THE PATIENT DEVELOPED A STERILE ABSCESS. THE INVOLVED SURGEON DID STATE THAT THERE WAS A VERY HIGH CHANCE THAT IT WAS THE SYNTHETIC DURA THAT CAUSED THE PROBLEM. BIOGLUE IS NOT AN INDICATED IN NEUROSURGERY IN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOGLUE SURGICAL ADHESIVE | SURGICAL ADHESIVE | MFI | CRYOLIFE, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |