X-TRA TRACTION SHOE COVER
Received Apr 25, 2008 · Event occurred Mar 27, 2008
Report 2083545-2008-00002 · MDR key 1034875
Device
Product problems
- Device Slipped
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT HAS BEEN REPORTED TO THE MANUFACTURER BY THE CUSTOMER THAT THERE IS LESS GRIP ON THE SHOE COVERS THAN BEFORE. THEY ALLEGED THAT WHEN YOU GRIP THE SHOE COVER OVER YOUR HAND YOU CAN SEE HOW IT SLIDES AND DOES NOT GRIP. THERE WAS NO REPORT OF SERIOUS INJURY TO DEATH AS A RESULT OF THIS PRODUCT. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED.
Additional Manufacturer Narrative
THE INCIDENT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. TO DATE, A ROOT CAUSE HAS NOT BEEN IDENTIFIED. INVESTIGATION PROCESS IS ON-GOING. A FOLLOW-UP REPORT WILL BE PROVIDED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.