FDA Adverse Event
Malfunction
Summary report: N
CUB PEDIATRIC CRIB- FIXED BASE
MDR report key: 3023808
·
Received March 27, 2013
Report
- Report Number
- 0001831750-2013-02611
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 8, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FMS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE CASTER BROKE OFF DUE TO SHIPPING. 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 |
|---|---|---|---|---|---|---|---|
| 126155 | CUB PEDIATRIC CRIB- FIXED BASE | BED, PEDIATRIC OPEN HOSPITAL | FMS | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |