OtherBWP
SHOE COVER, SMS, NON-SKID, X-L S
Received Jun 4, 2007 · Event occurred May 1, 2007
Report 1417592-2007-00025 · MDR key 863137
Device
Generic name
Shoe Cover, Operating Room
Manufacturer
Medline Industries, Inc.Model number
NON28859Lot number
4502862803 - 5CS
Product problems
- Component Missing
Patient
YR
- Fall
Narrative
Additional Manufacturer Narrative
SAMPLES RECEIVED AND SENT TO MFR FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED ONCE THE RESULTS ARE RECEIVED.
Description of Event or Problem
THE FACILITY STATED, THERE WERE THREE SEPARATE OCCURRENCES RELATED TO THE USE OF THE SHOE COVERS IN A ONE WEEK PERIOD. TWO OF THE OCCURRENCES OCCURRED IN THE OR AND ONE IN THE NURSERY. THE COVERS WERE ALLEGED TO BE MISSING THE NON-SKID STRIPS AND THREE EMPLOYEES FELL WHEN WALKING IN THEM. NO SERIOUS INJURY OCCURRED AS THE RESULT OF THE FALLS AND NO MEDICAL INTERVENTION WAS REQUIRED.