FDA Adverse Event
Malfunction
Summary report: N
EYE SURGERY STRETCHER OBS 3/07
MDR report key: 2942481
·
Received February 4, 2013
Report
- Report Number
- 0001831750-2013-00693
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- January 10, 2013
- Report Date
- January 10, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - HEAD PIECE; MATTRESS; VELCRO.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SIDE RAILS WERE NOT LATCHING PROPERLY IN THE UPRIGHT POSITION, THE MATTRESS WAS NO LONGER SECURELY ATTACHED TO THE LITTER, AND THE ARTICULATING HEAD PIECE WAS UNABLE TO HOLD POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46128 | EYE SURGERY STRETCHER OBS 3/07 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO | 1069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |