FDA Adverse Event
Malfunction
Summary report: N
SM104 MSERIES W5TH WHL
MDR report key: 1893729
·
Received November 2, 2010
Report
- Report Number
- 1831750-2010-03465
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Date of Event
- October 6, 2010
- Report Date
- October 6, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THERE WAS NO KNEE FUNCTION, AND THE OIL LEAKED ONTO THE FLOOR. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM104 MSERIES W5TH WHL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP., MEDICAL DIV. | 1005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |