FDA Adverse Event
Malfunction
Summary report: N
XPRT SLEEP SURFACE
MDR report key: 2841698
·
Received October 24, 2012
Report
- Report Number
- 1313850-2012-00314
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Date of Event
- September 29, 2012
- Report Date
- September 29, 2012
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- FNM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE MATTRESS COVER WAS TORN AND THERE ARE SIGNS OF FLUID INTRUSION. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XPRT SLEEP SURFACE | MATTRESS | FNM | STRYKER CORP DBA GAYMAR | 2950000000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |