ZIMMER ULTRACARE WOUND SHEET
Received May 25, 2012 · Event occurred May 1, 2012
Report 1035617-2012-00003 · MDR key 2593572
Device
Generic name
Zimmer Ultracare Wound Sheet
Manufacturer
Zimmer SurgicalModel number
NACatalog number
00-8600-059-00
Lot number
NA
Product problems
- Moisture Damage
- Material Integrity Problem
Patient
Not reported
- Peeling
- Skin Irritation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE ZIMMER ULTRACARE WOUND SHEET IS HOLDING IN MOISTURE AND CAUSING SKIN IRRITATION. ADDITIONAL CLINICAL F/U INDICATED THAT THE SHEETING WAS REPORTED TO HAVE BEEN USED FOR A PREMATURE INFANT THAT WAS IN A THERMOSTATICALLY CONTROLLED (35-37 DEGREE CELSIUS) ENVIRONMENT. AFTER "A BRIEF PERIOD" THE CUSTOMER NOTED THE INFANT'S SKIN TO BE RED AND PEELING. AN OINTMENT WAS APPLIED TO TREAT THE SKIN.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO THE MFR. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.