FDA Adverse Event
Malfunction
Summary report: N
SM104 MSERIES W5TH WHLOBS3/07
MDR report key: 3023893
·
Received March 27, 2013
Report
- Report Number
- 0001831750-2013-02613
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 8, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE LEFT AND RIGHT SIDERAILS WERE DIFFICULT TO LOCK DUE TO BENT SPINDLES AND THE RIGHT SIDE WAS MISSING THE SPINDLE CAP. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125337 | SM104 MSERIES W5TH WHLOBS3/07 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |