FDA Adverse Event
Malfunction
Summary report: N
EYE STRETCHER CHAIR
MDR report key: 2132334
·
Received June 13, 2011
Report
- Report Number
- 1831750-2011-05854
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- May 16, 2011
- Report Date
- May 16, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVAL RESULT: IV POLE BRACKET.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THERE WAS A BROKEN WELD ON THE PATIENT'S RIGHT IV POLE BRACKET EXPOSING SHARP EDGES. THE JACK PUMP PEDAL WAS ALSO BROKEN AND COULD NOT BE PUMPED UP. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EYE STRETCHER CHAIR | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 5051 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |