FDA Adverse Event
Malfunction
Summary report: N
REVOLUTION
MDR report key: 3983122
·
Received July 15, 2014
Report
- Report Number
- 3983122
- Event Type
- Malfunction
- Date Received
- July 15, 2014
- Date of Event
- July 3, 2014
- Report Date
- July 15, 2014
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- JDZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- ME, US
- Reporter Occupation
- NURSE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 413727 | REVOLUTION | MIXER, CEMENT, FOR CLINICAL USE | JDZ | STRYKER INSTRUMENTS | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |