PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE EXPERIENCED A "FACIAL REACTION" WHILE HANDLING PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED (ALLERGY MEDICATION).

Additional Manufacturer Narrative

A STERIS ACCOUNT MANAGER ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND LEARNED THE ROOM IN WHICH THE EMPLOYEE WAS HANDLING THE PROLYSTICA LACKED PROPER VENTILATION. WHILE ONSITE, THE STERIS ACCOUNT MANAGER OPENED THE ROOM'S AIR VENTS TO HELP RESTORE PROPER VENTILATION. THE PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER SAFETY DATA SHEET STATES, "SECTION 7: HANDLING AND STORAGE, PROVIDE GOOD VENTILATION IN PROCESS AREA TO PREVENT FORMATION OF VAPOR." STERIS ACCOUNT MANAGER COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION WITH THE PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER, SPECIFICALLY, IN ENSURING PROPER VENTILATION WHERE THE PRODUCT IS BEING USED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUBJECT LOT 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.