FDA Adverse Event
Malfunction
Summary report: N
SMARTLIFE LARGE ASEPTIC HOUSING
MDR report key: 3792190
·
Received April 8, 2014
Report
- Report Number
- 0001811755-2014-01634
- Event Type
- Malfunction
- Date Received
- April 8, 2014
- Date of Event
- April 8, 2014
- Report Date
- April 8, 2014
- Manufacturer
- STRYKER INSTRUMENTS, INSTRUMENTS DIV.
- Product Code
- HWE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- *
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212908 | SMARTLIFE LARGE ASEPTIC HOUSING | INSTRUMENT SURGICAL ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | HWE | STRYKER INSTRUMENTS, INSTRUMENTS DIV. | 13189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |