inforMED
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

Model number

NON28859

Lot 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.