PROLYSTICA

Description of Event or Problem

THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT AN EMPLOYEE OBTAINED BURNS ON THEIR KNEES WHILE HANDLING PROLYSTICA CONCENTRATE ENZYMATIC CLEANER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AND RECEIVED ANTIBIOTICS.

Additional Manufacturer Narrative

THROUGH FOLLOW-UP WITH USER FACILITY PERSONNEL, IT WAS DISCOVERED THAT WHEN THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS LIFTING TRAYS OUT OF THE PROCESSING SINK WHEN SOME OF THE CLEANER MADE CONTACT WITH HER KNEES. THE EMPLOYEE'S APRON WAS NOT COVERING HER KNEES, SUBSEQUENTLY CAUSING THE REPORTED EVENT. THE PROLYSTICA SDS STATES, "AVOID ALL UNNECESSARY EXPOSURE. PERSONAL PROTECTIVE EQUIPMENT SHOULD BE SELECTED BASED UPON THE CONDITIONS UNDER WHICH THIS PRODUCT IS HANDLED OR USED. PROTECTIVE CLOTHING, GLOVES, PROTECTIVE GOGGLES." STERIS PROVIDED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF PROLYSTICA, SPECIFICALLY ON WEARING THE PROPER PPE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE LOT/SERIAL NUMBER IS UNKNOWN; THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.

Additional Manufacturer Narrative

CONTRARY TO THE INITIAL REPORT, STERIS DID NOT PROVIDE THE IN-SERVICE TRAINING BUT RATHER, THE TRAINING WAS CONDUCTED BY THE USER FACILITY'S HEALTH AND SAFETY DEPARTMENT.