FDA Adverse Event
Summary report: N
MATTRESS COVER FOR MEDICAL PURPOSES
MDR report key: 4166112
·
Received October 13, 2014
Report
- Report Number
- 1531186-2014-04841
- Date Received
- October 13, 2014
- Report Date
- September 24, 2014
- Manufacturer
- UNKNOWN
- Product Code
- FMW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE END-USER STATES HIS MOM BOUGHT THE BED A FEW YEARS AGO. HE ALLEGES THE MATTRESS MAY HAVE BEEN PREVIOUSLY USED OR THEY RECEIVED A DEFECTIVE MATTRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 646003 | MATTRESS COVER FOR MEDICAL PURPOSES | 880.6190 | FMW | UNKNOWN | 5185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |