MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT THAT THE CLEAR SCREEN IS COMING APART AT THE DRAPE, EXPOSING PATIENT AND BREAKING STERILITY. INCISE ADHESION IS HARDER TO REMOVE FROM PATIENT SKIN. 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 CLEAR SCREEN IS COMING APART AT THE DRAPE, EXPOSING PATIENT AND BREAKING STERILITY. INCISE ADHESION IS HARDER TO REMOVE FROM PATIENT SKIN.