FDA Adverse Event
Other
Summary report: N
SYMMETRIC AIRE; PENN-NYLA
MDR report key: 2357557
·
Received November 22, 2011
Report
- Report Number
- 1313850-2011-00446
- Event Type
- Other
- Date Received
- November 22, 2011
- Date of Event
- October 28, 2011
- Report Date
- October 28, 2011
- Manufacturer
- STRYKER CORP., DBA, GAYMAR
- Product Code
- IKY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE INITIAL COMPLAINT OF SAGGING IS NOT LIKELY TO CONTRIBUTE TO OR CAUSE SERIOUS INJURY OR DEATH, AS THE PT WOULD STILL BE SUPPORTED BY THE BOTTOM LAYER FOAM AND THE FOAM INSIDE THE AIR CELLS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MATTRESS WAS SAGGING. UPON EVAL, WHEN THE COVER WAS OPENED STAINING WAS PRESENT, WHICH SUGGESTS FLUID INGRESS OCCURRED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYMMETRIC AIRE; PENN-NYLA | MATTRESS | IKY | STRYKER CORP., DBA, GAYMAR | 2750100000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |