InjuryFMP
PREMIUM HEEL GUARD
Received Mar 10, 2015 · Event occurred Jan 1, 2015
Report 2020362-2015-00031 · MDR key 4589049
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
ASKU
- Skin Erosion
Narrative
Description of Event or Problem
CUSTOMER REPORTED THE PT HAD HEEL BLISTER AND A SMALL DEEP TISSUE INJURY (DTI).
Additional Manufacturer Narrative
PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN RECEIVED. THIS SUBMISSION IS BASED SOLELY ON THE USER FACILITY'S REPORTED ISSUE. (B)(4).