InjuryFMW
ISOFLEX 35X84X6 NYLON
Received Mar 22, 2013 · Event occurred Feb 26, 2013
Report 0001831750-2013-02353 · MDR key 3017968
Device
Generic name
Cover, Mattress (medical Purposes)
Manufacturer
Stryker Medical-kalamazooCatalog number
2800100010
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pressure Sore/Ulcer
Narrative
Additional Manufacturer Narrative
CUSTOMER PROVIDED WITH A NEW MATTRESS.
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.