inforMED
InjuryFOH

ISOFLEX MEDSURG MATTRESS MODEL

Received Jun 30, 2011 · Event occurred Jun 1, 2011

Report 1313850-2011-00157 · MDR key 2158100

Device

Generic name

Mattress

Model number

2800100997

Catalog number

NA

Lot number

NA

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • Pressure Sore/Ulcer

Narrative

Additional Manufacturer Narrative

CUSTOMER HAS BEEN UNRESPONSIVE TO MULTIPLE ATTEMPTS AT OBTAINING ADDITIONAL INFO ON THIS REPORTED EVENT. F/U WILL BE FILED AS NECESSARY BASED UPON INVESTIGATIONS RESULTS.

Description of Event or Problem

IT WAS REPORTED THAT A PT RECENTLY DEVELOPED AN UNSTAGEABLE PRESSURE ULCER.