FDA Adverse Event
Other
Summary report: N
XPRT SLEEP SURFACE
MDR report key: 2038705
·
Received March 25, 2011
Report
- Report Number
- 1313850-2011-00047
- Event Type
- Other
- Date Received
- March 25, 2011
- Date of Event
- September 23, 2010
- Report Date
- September 24, 2010
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- FNM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: PRODUCT REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE COVER HAD FLUID SEEPING THROUGH IT. PATIENT INVOLVEMENT WAS REPORTED, HOWEVER, IT IS NOT KNOWN IF THERE WERE ANY ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XPRT SLEEP SURFACE | MATTRESS | FNM | STRYKER CORP DBA GAYMAR | 2950 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |