FDA Adverse Event
Malfunction
Summary report: N
PRESS PEDIC PRE NYL 35X80
MDR report key: 2111363
·
Received May 18, 2011
Report
- Report Number
- 1313850-2011-00112
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 2011
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- FMW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: MATTRESS WAS DISCARDED, AND COVERS MAY BE REPLACED UNDER WARRANTY BASED ON INVESTIGATION RESULTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT URINE INGRESSED THROUGH THE TOP AND BOTTOM COVERS TO THE MATTRESS. THERE WAS PT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRESS PEDIC PRE NYL 35X80 | MATTRESS COVER | FMW | STRYKER CORP DBA GAYMAR | PRN3580 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |