FDA Adverse Event
Malfunction
Summary report: N
XPRT MATTRESS W/O PENDANT
MDR report key: 2760308
·
Received September 20, 2012
Report
- Report Number
- 1313850-2012-00296
- Event Type
- Malfunction
- Date Received
- September 20, 2012
- Date of Event
- August 27, 2012
- Report Date
- August 27, 2012
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- FMW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT BLOOD SOAKED THROUGH THE MATTRESS COVER. THERE WAS PT INVOLVEMENT; HOWEVER, THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XPRT MATTRESS W/O PENDANT | MATTRESS | FMW | STRYKER CORP DBA GAYMAR | 2950200000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |