FDA Adverse Event
Malfunction
Summary report: N
BEAVER
MDR report key: 158635
·
Received March 23, 1998
Report
- Report Number
- 1211998-1998-00001
- Event Type
- Malfunction
- Date Received
- March 23, 1998
- Date of Event
- February 2, 1998
- Manufacturer
- BECTON DICKINSON & CO.
- Product Code
- GES
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IN AN ATTEMPT AT PASSING THE BEAVER BLADE INTO THE KNEE THROUGH THE OUTER MEDIAL PORTAL, THE BLADE BROKE AND THROUGH MULTIPLE ATTEMPTS, THE BLADE WAS WASHED INTO THE POSTERIOR CONFINES OF THE POSTEROLATERAL MARGIN OF THE TIBIAL PLATEAU OVE ITS POSTERIOR RIM. PHYSICIAN WAS UNABLE TO RETRIEVE THE BLADE. PT ARRIVED TO E.R IN PAIN. PT TAKEN TO SURGERY AS AN EMERGENCY AND THE BLADE WAS RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BEAVER | 4MM ARTHRO LOK BLADE | GES | BECTON DICKINSON & CO. | * | 0211728313 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Required Intervention |