FDA Adverse Event
Summary report: N
MATTRESS COVER FOR MEDICAL PURPOSES
MDR report key: 4199418
·
Received October 24, 2014
Report
- Report Number
- 1531186-2014-05067
- Date Received
- October 24, 2014
- Report Date
- September 8, 2014
- Manufacturer
- GRAND HEALTHCARE CO., LTD.
- Product Code
- FMW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT A CG9701 MATTRESS HAS DEFLATED IN THE MIDDLE, AND WHEN PATIENT IS MOVED TO ANOTHER SECTION, IT WILL ALSO DEFLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679574 | MATTRESS COVER FOR MEDICAL PURPOSES | 880.6190 | FMW | GRAND HEALTHCARE CO., LTD. | CG9701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |