FDA Adverse Event
Malfunction
Summary report: N
BASSINET, EURO STYLE
MDR report key: 2382349
·
Received November 16, 2011
Report
- Report Number
- 1831750-2011-12087
- Event Type
- Malfunction
- Date Received
- November 16, 2011
- Date of Event
- October 18, 2011
- Report Date
- October 19, 2011
- Manufacturer
- IWC
- Product Code
- FMS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
RESULT: PLASTIC TUB.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE IS A CRACK IN THE CORNER OF THE BASSINET PLASTIC TUB AND SHARP EDGES WERE PRESENT. THERE WAS NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BASSINET, EURO STYLE | MANUAL PATIENT TRANSFER DEVICE | FMS | IWC | 4400424000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |