FDA Adverse Event
Death
Summary report: N
BIOGLUE SURGICAL ADHESIVE
MDR report key: 513115
·
Received February 25, 2004
Report
- Report Number
- 1063481-2004-00002
- Event Type
- Death
- Date Received
- February 25, 2004
- Report Date
- January 26, 2004
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MFI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ACCORDING TO LIMITED INFOMATION, BIOGLUE SURGICAL ADHESIVE WAS USED ON THE EXTERNAL SURFACE OF THE HEART DURING REPLACEMENT OF AN AORTIC VALVE (TYPE OF PROCEDURE IS UNKNOWN). ACCORDING TO THE REPORT, BIOGLUE SURGICAL ADHESIVE WAS FOUND IN THE BRAIN TISSUE (SPECIFIC LOCATION UNKNOWN) UPON AUTOPSY. ADDITIONAL INFO ABOUT THE PT AND THE EVENT HAS NOT BEEN PROVIDED TO THE MFR TO DATE. NO FURTHER INFO IS AVAILABLE AND IS ALSO NOT ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOGLUE SURGICAL ADHESIVE | SURGICAL ADHESIVE | MFI | CRYOLIFE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |