FDA Adverse Event
Other
Summary report: N
XPRT W/PENDANT W/DARTEX COVER
MDR report key: 2065570
·
Received April 6, 2011
Report
- Report Number
- 1313850-2011-00068
- Event Type
- Other
- Date Received
- April 6, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 8, 2011
- Manufacturer
- STRYKER CORP., DBA GAYMAR
- Product Code
- FNM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DUE TO SIGNS OF CUSTOMER ABUSE, THE CUSTOMER WAS INFORMED THEY WOULD BE RESPONSIBLE FOR REPLACEMENT OF MATTRESS. THE CONTAMINATED MATTRESS/COVER DID NOT QUALIFY FOR NO CHARGE REPLACEMENT UNDER WARRANTY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MATTRESS HAD FLUID INGRESS. IT WAS FURTHER REPORTED THAT THE TOP COVER HAD ABRASIONS AND PUNCTURE MARKS. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XPRT W/PENDANT W/DARTEX COVER | MATTRESS | FNM | STRYKER CORP., DBA GAYMAR | 2950100002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |