inforMED
InjuryFMW

REM 3000 35X84X6 DARTEX W FB

Received Sep 20, 2012 · Event occurred Aug 23, 2012

Report 1313850-2012-00294 · MDR key 2757044

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Product code (FMW)
Model (DG2700-600-015)

Device

Generic name

Mattress

Model number

DG2700-600-015

Catalog number

NA

Lot number

NA

Product problems

  • Moisture Damage

Patient

Not reported

  • No Code Available

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THERE HAS BEEN ONE ALLEGED REPORT OF WOUNDS WORSENING BY A PT WITH PRE-EXISTING WOUNDS. THE SAME UNIT WAS REPORTED TO HAVE LIQUID INGRESS NOTED AFTER BEING REMOVED FROM SERVICE. NO SERIAL NUMBER HAS BEEN PROVIDED.

Additional Manufacturer Narrative

THE PRODUCT HAS NOT BEEN RETURNED TO THE MFR FOR EVAL.