InjuryFMW
ISOFLEX 35X84X6 NYLON
Received Mar 22, 2013 · Event occurred Feb 26, 2013
Report 0001831750-2013-02348 · MDR key 3017919
Device
Generic name
Cover, Mattress (medical Purposes)
Manufacturer
Stryker Medical-kalamazooCatalog number
2800100010
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Pressure Sore/Ulcer
Narrative
Description of Event or Problem
IT WAS ALLEGED BY THE CUSTOMER THAT THEY HAVE SEEN PATIENTS DEVELOP PRESSURE ULCERS WHILE USING AN ISOFLEX MATTRESS. HOWEVER, AS THE CUSTOMER STATED THEY DID NOT RECORD ANY SERIAL NUMBERS FOR THE REPORTED PRESSURE ULCERS FOUND ON THEIR ISOFLEX MATTRESSES, IT IS NOT KNOWN IF THIS MATTRESS IS ALLEGED TO HAVE CAUSED OR CONTRIBUTED TO A PRESSURE ULCER DEVELOPMENT.
Additional Manufacturer Narrative
CUSTOMER PROVIDED WITH A NEW MATTRESS.