FDA Adverse Event
Malfunction
Summary report: N
BASSINET, EURO STYLE
MDR report key: 2012802
·
Received March 3, 2011
Report
- Report Number
- 1831750-2011-02122
- Event Type
- Malfunction
- Date Received
- March 3, 2011
- Date of Event
- February 4, 2011
- Report Date
- February 4, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FMS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVAL: OTHER - CHART HOLDER.
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE CHART HOLDER WAS BROKEN AND HAS SHARP EDGES. THERE WAS PT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BASSINET, EURO STYLE | MANUAL PATIENT TRANSFER DEVICE | FMS | STRYKER MEDICAL | 4400424000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |