VAPROX

Additional Manufacturer Narrative

INVESTIGATION OF THE EVENT IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. IT SHOULD BE NOTED THAT THIS SPECIFIC MODEL IS NOT SOLD IN THE UNITED STATES, SO IT IS NOT IN GUDID.

Description of Event or Problem

THE DISTRIBUTOR REPORTED THAT USER FACILITY WAREHOUSE AND STERILIZATION EMPLOYEES OBTAINED BURNS TO THEIR HANDS WHILE HANDLING LEAKING PACKAGES OF VAPROX HC STERILANT. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.