FDA Adverse Event
Malfunction
Summary report: N
EYE STRETCHER CHAIR
MDR report key: 2931932
·
Received January 28, 2013
Report
- Report Number
- 0001831750-2013-00458
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Date of Event
- January 7, 2013
- Report Date
- January 7, 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 BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE HEAD SECTION WAS NOT STAYING ENGAGED. STRYKER TECHNICIAN EVALUATED THE UNIT AND FOUND THE HEAD SECTION TO BE OPERATING TO SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38332 | EYE STRETCHER CHAIR | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |