VAPROX

Additional Manufacturer Narrative

THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES AT THE TIME OF THE REPORTED EVENT. THE INSTRUCTIONS FOR USE FOR THE VAPROX HC STERILANT STATES, "WARNING - DO NOT USE IF STERILANT PACKAGING IS DAMAGED." ALSO, "PRECAUTIONARY STATEMENTS IF ON SKIN (OR HAIR): TAKE OFF IMMEDIATELY ALL CONTAMINATED CLOTHING. RINSE SKIN WITH WATER / SHOWER." THE VAPROX HC STERILANT SAFETY DATA SHEET STATES (4), "HAND PROTECTION: WEAR PROTECTIVE GLOVES". THE SHIPPING CASE INSERT ALSO STATES, "WEAR PERSONAL PROTECTIVE EQUIPMENT TO HANDLE CARTRIDGE; CHEMICAL RESISTANT GLOVES" THE EMPLOYEE WAS COUNSELED ON THE IMPORTANCE OF WEARING CHEMICAL RESISTANT GLOVES WHILE HANDLING VAPROX HC STERILANT. THE DEVICE HISTORY RECORD FOR THE LOT SUBJECT OF THE REPORTED EVENT WAS REVIEWED AND CONFIRMED THE LOT WAS MANUFACTURED TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

INVESTIGATION OF THE REPORTED EVENT IS 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 USER FACILITY REPORTED AN EMPLOYEE OBTAINED A BURN ON THEIR ARM WHILE HANDLING VAPROX HC STERILANT. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.