FDA Adverse Event
Malfunction
Summary report: N
ROUND BUR, MEDIUM, 2.4MM
MDR report key: 1040676
·
Received May 7, 2008
Report
- Report Number
- 1017294-2008-00199
- Event Type
- Malfunction
- Date Received
- May 7, 2008
- Report Date
- April 8, 2008
- Manufacturer
- CONMED LINVATEC
- Product Code
- HTT
- 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 EVAL. DURING VISUAL INSPECTION, CONMED LINVATEC CONFIRMED THE REPORTED PROBLEM. A DEFORMITY WAS OBSERVED IN THE PROXIMAL CORNER OF THE BLISTER PACKAGING. FURTHER INVESTIGATION FOUND THE PACKAGING TO BE COMPROMISED. AN INVESTIGATION FOR THIS FAILURE REMAINS IN PROCESS.
Description of Event or Problem · 1
OUR DISTRIBUTOR REPORTED THAT THE PACKAGING CONTAINING THIS STERILE BUR 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 | ROUND BUR, MEDIUM, 2.4MM | STERILE BUR | HTT | CONMED LINVATEC | NA | BBD16202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |