FDA Adverse Event
Summary report: N
MATTRESS COVER FOR MEDICAL PURPOSES
MDR report key: 4187515
·
Received October 21, 2014
Report
- Report Number
- 1531186-2014-04968
- Date Received
- October 21, 2014
- Report Date
- September 26, 2014
- Manufacturer
- GRAND HEALTHCARE CO., LTD.
- Product Code
- FMW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
BEN STATES THAT HE IS NOT FOR SURE THAT THE PUMP IS AT FAULT. WILL WAIT FOR PATIENT TO COME IN AND TEST THE UNIT AND CALL BACK. PUMP WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 667842 | MATTRESS COVER FOR MEDICAL PURPOSES | 880.6190 | FMW | GRAND HEALTHCARE CO., LTD. | CG9701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |