inforMED
MalfunctionFMW

HILL-ROM PROGRESS SPECIALLY BED MATTRESS COVERLETS

Received Apr 29, 2019 · Event occurred Apr 19, 2019

Report MW5086257 · MDR key 8565057

Device

Generic name

Cover, Mattress

Manufacturer

Hill-rom, Inc.

Product problems

  • Inadequate Instructions for Healthcare Professional
  • Device Emits Odor

Patient

Not reported

  • No Information
  • No Information

Narrative

Description of Event or Problem

SAFETY CONCERN RELATED TO LACK OF PROPER CLEANING AND DISINFECTION (I.E., STAINS AND ODOR). THE MFR RECOMMENDATIONS INCLUDED SURFACE CLEANING AND DISINFECTION OF COVERLETS, VERSUS TRADITIONAL COVERLET REMOVAL AND LAUNDERING AFTER EACH PT. COVERLETS HAVE NOT BEEN REMOVED FROM MATTRESSES SINCE PURCHASE. UPON FURTHER INSPECTION OF PAD AND MATTRESS BENEATH COVERLETS, STAINING, CRUSTING, AND FOUL ODOR WERE IDENTIFIED. FDA SAFETY REPORT ID # (B)(4).