FDA Adverse Event
Malfunction
Summary report: N
VCARE
MDR report key: 1070734
·
Received July 2, 2008
Report
- Report Number
- 1320894-2008-00088
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Date of Event
- June 6, 2008
- Report Date
- July 2, 2008
- Manufacturer
- CONMED CORPORATION
- Product Code
- LKF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN I RECEIVE THE INVESTIGATION REPORT, I WILL FILE A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT "DR (B) (6) STATES THAT HE HAS EXPERIENCED BROKEN HANDLE PART OF THE VCARE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VCARE | UTERINE MANIPULATOR | LKF | CONMED CORPORATION | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |