FDA Adverse Event
Death
Summary report: N
BIOGLUE SURGICAL ADHESIVE
MDR report key: 1673178
·
Received April 28, 2010
Report
- Report Number
- 1063481-2010-00013
- Event Type
- Death
- Date Received
- April 28, 2010
- Date of Event
- March 23, 2010
- Report Date
- April 27, 2010
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MUQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFO WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
Description of Event or Problem · 1
ACCORDING TO THE REPORT, THE SURGEON PERFORMED A RIGHT THORACOTOMY ON A PT. A REOPERATION WAS REQUIRED DUE TO AN ACCUMULATION OF 20 ML OF FLUID AT THE DESCENDING THORACIC DUCT. DURING THE REOPERATION PROCEDURE, BIOGLUE WAS USED TO REINFORCE THE THORACIC DUCT BECAUSE IT WAS "FLIMSY." THE PT WAS UNABLE TO SURVIVE THE REOPERATION PROCEDURE. THE SURGEON FELT THAT IT WAS POSSIBLE THAT THE PT DIED OF ANAPHYLAXIS. THIS APPLICATION REPRESENTS AN OFF - LABEL USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOGLUE SURGICAL ADHESIVE | SURGICAL ADHESIVE | MUQ | CRYOLIFE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |