inforMED
InjuryFMW

ISOFLEX 35X84 DARTEX W/FB

Received Sep 26, 2012 · Event occurred Aug 29, 2012

Report 1313850-2012-00298 · MDR key 2767028

Device

Generic name

Mattress

Model number

2800000000

Catalog number

NA

Lot number

NA

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • Tissue Damage

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PT'S SKIN BROKE DOWN WHILE ON THE MATTRESS.

Additional Manufacturer Narrative

THE PRODUCT IS NOT BEING RETURNED TO THE MFR FOR EVAL; NO PRODUCT MALFUNCTION IS ALLEGED.