FDA Adverse Event
Injury
Summary report: N
FLOSEAL MATRIX HEMOSTATIC SEALANT
MDR report key: 343606
·
Received July 20, 2001
Report
- Report Number
- 2952600-2001-00003
- Event Type
- Injury
- Date Received
- July 20, 2001
- Report Date
- June 20, 2001
- Manufacturer
- FUSION MEDICAL TECHNOLOGIES, INC.
- Product Code
- LMF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FLOSEAL MATRIX HEMOSTATIC SEALANT WAS USED BY A SURGEON DURING A CARDIAC SURGERY PROCEDURE TO STOP A PERSISTENT SMALL BLEED AT THE SUTURE LINE PLACED TO CLOSE THE HOLE IN THE VENTRICLE CREATED BY THE CARDIOPLEGIA CANNULA. BLEEDING WAS STOPPED AND THE PATIENT, WAS TRANSFERRED TO ICU POST-OPERATIVELY. A FEW HOURS LATER THE PT WENT INTO SHOCK AND UNDERWENT EMERGENCY SURGERY. THE SURGEON OBSERVED BLEEDING AT THE SAME SITE WHERE FLOSEAL HAD BEEN APPLIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32850 | FLOSEAL MATRIX HEMOSTATIC SEALANT | STERILE HEMOSTATIC SEALANT KIT | LMF | FUSION MEDICAL TECHNOLOGIES, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |