FDA Adverse Event
Other
Summary report: N
BIOGLUE SURGICAL ADHESIVE
MDR report key: 515525
·
Received March 11, 2004
Report
- Report Number
- 1063481-2004-00003
- Event Type
- Other
- Date Received
- March 11, 2004
- Report Date
- February 9, 2004
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MFI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
A PT OF UNKNOWN AGE AND MEDICAL HISTORY UNDERWENT A LUMBER DISC SURGERY USING BIOGLUE SURGICAL ADHESIVE (NOT AN APPROVED INDICATION IN THE UNITED STATES) AT APPROXIMATELY THE BEGINNING OF JANUARY (SPECIFIC DATE UNKNOWN). ACCORDING TO THE SURGEON, THE PT EXPERIENCED LOWER EXTREMITY NUMBNESS POST-OPERATIVELY AND A RE-OPERATION WAS PERFORMED IN ORDER TO RELIEVE THE NERVE COMPRESSION. THE PT'S CURRENT CONDITION IS NOT KNOWN AND THE EVENT DETAILS ARE CURRENTLY BEING HANDLED BY RISK MANAGEMENT AT THE SURGICAL FACILITY. NO FURTHER INFORMATION ABOUT THE CASE HAD BEEN MADE AVAILABLE TO CRYOLIFE TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOGLUE SURGICAL ADHESIVE | SURGICAL ADHESIVE | MFI | CRYOLIFE, INC. | NOT APPLICABLE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| O |