FDA Adverse Event
Death
Summary report: N
BIOGLUE SURGICAL ADHESIVE
MDR report key: 1601050
·
Received February 10, 2010
Report
- Report Number
- 1063481-2010-00002
- Event Type
- Death
- Date Received
- February 10, 2010
- Date of Event
- December 24, 2009
- Report Date
- February 10, 2010
- Manufacturer
- CRYOLIFE
- Product Code
- MUQ
- PMA / PMN Number
- P010003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADD'L INFO WILL BE PROVIDED IN THE F/U REPORT.
Description of Event or Problem · 1
ACCORDING TO THE REPORT, THE PT HAD EMERGENCY SURGERY FOR AN AORTIC ASCENDING THORACIC ANEURYSM IN BIOGLUE WAS USED. THE PT DIED ON (B) (6) 2009 FROM MULTIPLE SYSTEM FAILURE DUE TO SEPSIS. THE SOURCE OF THE SEPSIS IS PRESUMED TO BE DUE TO "WOUND OF SURGICAL/MEDIASTINUM AND PNEUMONIA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOGLUE SURGICAL ADHESIVE | SURGICAL ADHESIVE | MUQ | CRYOLIFE | BG3515-5-US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Death |