FDA Adverse Event
Other
Summary report: N
ISOFLEX 35X84 DARTEX W/FB
MDR report key: 2395313
·
Received December 21, 2011
Report
- Report Number
- 1313850-2011-00485
- Event Type
- Other
- Date Received
- December 21, 2011
- Date of Event
- October 25, 2011
- Report Date
- November 4, 2011
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- FNM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: CUSTOMER WAS INFORMED THAT THE FOAM OR ENTIRE MATTRESS SHOULD BE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT FLUID HAD INGRESSED INTO THE MATTRESS. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX 35X84 DARTEX W/FB | MATTRESS | FNM | STRYKER CORP DBA GAYMAR | 2800100000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |