FDA Adverse Event
Malfunction
Summary report: N
CRANIOTOME BLADE, NEURO 1.8 X 29.2MM
MDR report key: 1040674
·
Received May 7, 2008
Report
- Report Number
- 1017294-2008-00196
- Event Type
- Malfunction
- Date Received
- May 7, 2008
- Report Date
- April 8, 2008
- Manufacturer
- CONMED LINVATEC
- Product Code
- HWE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BLADE AND PACKAGING FOR EVALUATION. DURING TESTING, CONMED LINVATEC CONFIRMED THE REPORTED PROBLEM. A PIN HOLE WAS NOTED IN THE TRAY CONTAINING THIS STERILE BLADE. FURTHER INVESTIGATION FOUND THE PACKAGING COMPROMISED. AN INVESTIGATION FOR THIS FAILURE REMAINS IN PROCESS.
Description of Event or Problem · 1
OUR DISTRIBUTOR REPORTED THAT THE PACKAGING CONTAINING THIS STERILE BLADE HAS A DEFORMITY. THE DEFORMITY NOTED IS A PIN HOLE IN THE PACKAGING TRAY. THERE WAS NO PT INVOLVEMENT, INJURY OR SURGICAL DELAY RESULTING FROM THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRANIOTOME BLADE, NEURO 1.8 X 29.2MM | STERILE BLADE, NEURO | HWE | CONMED LINVATEC | NA | BBD15231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |