FDA Adverse Event
Malfunction
Summary report: N
LD304 MATERNITY BED
MDR report key: 2031383
·
Received February 24, 2011
Report
- Report Number
- 1831750-2011-01839
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- February 17, 2011
- Report Date
- February 17, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- HDD
- PMA / PMN Number
- K950889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: CALF SUPPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE FOOT RIGHT CALF SUPPORT WAS LOOSE. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LD304 MATERNITY BED | LABOR AND DELIVERY BED | HDD | STRYKER MEDICAL | 4701 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |