FDA Adverse Event
Injury
Summary report: N
XPRT SLEEP SURFACE
MDR report key: 3183012
·
Received June 21, 2013
Report
- Report Number
- 0001831750-2013-05694
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 16, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- IKZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP SUBMITTED TO INDICATE THAT THE MANUFACTURER DID NOT EVALUATE THE UNIT, AS THE MATTRESS WAS NOT IDENTIFIED OR MADE AVAILABLE BY THE FACILITY FOR EVALUATION BY A STRYKER TECHNICIAN. FACILITY DID NOT IDENTIFY UNIT INVOLVED IN ALLEGED EVENT.
Additional Manufacturer Narrative · 1
CONCLUSION - MANUFACTURERS INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE USER FACILITY THAT THE PATIENT'S SKIN BROKE DOWN WHILE ON THE MATTRESS.
Description of Event or Problem · 1
IT WAS REPORTED BY THE USER FACILITY THAT THE PATIENT'S SKIN BROKE DOWN WHILE ON THE MATTRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283646 | XPRT SLEEP SURFACE | BED, PATIENT ROTATION, POWERED | IKZ | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |