VAPROX

Additional Manufacturer Narrative

THE EMPLOYEE SUBJECT OF THE REPORTED EVENT STATED THAT THE BAG IN WHICH THE VAPROX CARTON WAS PRESENT WAS "WET" AND PROCEEDED TO REMOVE THE VAPROX CARTON FROM THE BAG. THROUGH FOLLOW UP WITH USER FACILITY PERSONNEL, IT WAS STATED THAT THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE HANDLING THE VAPROX. USER FACILITY PERSONNEL ALSO CONFIRMED THAT NO MEDIAL TREATMENT WAS SOUGHT OR ADMINISTERED. USER FACILITY PERSONNEL WERE COUNSELED ON THE PROPER HANDLING, STORAGE, AND DISPOSAL PRACTICES, INCLUDING THE IMPORTANCE OF WEARING PROPER PPE WHEN HANDLING THE PRODUCT. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE SUBJECT LOT WAS MANUFACTURED TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THE REPORTED EVENT TO BE ISOLATED FOR THE SUBJECT LOT.

Additional Manufacturer Narrative

INVESTIGATION IN PROCESS. A FOLLOW UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE EXPERIENCED BURNING TO THEIR FINGERS WHILE HANDLING VAPROX HC STERILANT. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.