FDA Adverse Event
Other
Summary report: N
CUB PEDIATRIC CRIB-HYD BASE
MDR report key: 2092925
·
Received May 11, 2011
Report
- Report Number
- 1831750-2011-04543
- Event Type
- Other
- Date Received
- May 11, 2011
- Date of Event
- April 11, 2011
- Report Date
- April 11, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FMS
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE FACILITY REPORTEDLY HAS EXAMINED THE UNIT, HOWEVER, THEY WILL NOT PROVIDE FEEDBACK NOR RESULTS TO STRYKER UPON REQUEST. THE ROOT CAUSE IS UNDETERMINED AS PRODUCT EVAL HAS NOT BEEN POSSIBLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT'S FOOT WAS CAUGHT BETWEEN THE SIDE RAIL SLATS TWICE AND BETWEEN THE SIDE RAIL SLAT AND THE ROUND METAL BAR NEAR THE ACTIVATION LEVER (USED TO RAISE AND LOWER THE SIDE RAIL) ON THE CRIB. THE CUSTOMER STATED THAT IT WAS THE SAME PT IN THE SAME CRIB IN ALL THREE INSTANCES. REPORTEDLY, SIDE RAIL PADS WERE NOT USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CUB PEDIATRIC CRIB-HYD BASE | BED, PEDIATRIC OPEN HOSPITAL | FMS | STRYKER MEDICAL | FL19H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |