FITRIGHT

Description of Event or Problem

IT WAS REPORTED THAT, THE COTTON IS COMING OUT, THEY ARE NOT PUT TOGETHER PROPERLY. WHEN THE PATIENT USES THE BRIEF AND IT IS WET THE COTTON TURNS INTO GEL TYPE AND IT IS LEAKING OUT ONTO THE SKIN.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE COTTON IS COMING OUT, AND THEY ARE NOT PUT TOGETHER PROPERLY. WHEN THE PATIENT USES THE BRIEF AND IT IS WET THE COTTON TURNS INTO JELLY AND IT IS LEAKING OUT ONTO THE 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.