FDA Adverse Event
Injury
Summary report: N
FTL
MDR report key: 919820
·
Received September 5, 2007
Report
- Report Number
- 1018233-2007-00059
- Event Type
- Injury
- Date Received
- September 5, 2007
- Report Date
- September 5, 2007
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE WAS RETURNED FOR EVAL. THE LOT NUMBER PROVIDED WAS INVALID, THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. THE PRODUCT IS MANUFACTURED USING A CONTROLLED AND VALIDATED MFG PROCESS. THE PRODUCT IS TERMINALLY STERILIZED BY IRRADIATION AND HAS UNDERGONE STERILIZATION VALIDATION AND DOSE AUDIT STUDIES IN ACCORDANCE WITH ISO 11137. ROUTINE PRODUCT BIOBURDEN MONITORING IS PERFORMED TO HELP SAFEGUARD STERILITY ASSURANCE. PRODUCT AND PACKAGING INSPECTION STAGES HAVE BEEN IMPLEMENTED IN CONJUNCTION WITH A VALIDATED PROCESS AND DOCUMENTED SYSTEMS TO HELP SAFEGUARD AND ASSURE PRODUCT QUALITY. BASELINE REPORT PREVIOUSLY PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FTL | FTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |