MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE INSTRUCTIONS DID NOT COINCIDE WITH THE ORIENTATIONS OF THE DRAPES, AND THERE WERE HOLES IN THE DRAPES. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

Description of Event or Problem

IT WAS REPORTED THAT THE INSTRUCTIONS DID NOT COINCIDE WITH THE ORIENTATIONS OF THE DRAPES, AND THERE WERE HOLES IN THE DRAPES.