inforMED
InjuryFMW

ISOFLEX 35X84 DARTEX W/FB

Received Nov 29, 2011 · Event occurred Nov 1, 2011

Report 1313850-2011-00460 · MDR key 2357679

Device

Generic name

Mattress

Model number

2800

Catalog number

NA

Lot number

NA

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • Pressure Sore/Ulcer

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PT DEVELOPED A PRESSURE ULCER.

Additional Manufacturer Narrative

MATTRESS NOT BEING RETURNED FOR EVAL.