ENZYMAX SPRAY GEL

Additional Manufacturer Narrative

WITH NO DEVICE IN HAND, ROOT CAUSE ANALYSIS OF THE ISSUE IS LIMITED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED SKIN IRRITATION IS CONSISTENT WITH THE KNOWN WARNINGS ON THE PRODUCT LABEL REGARDING DIRECT SKIN EXPOSURE. THE CAUSE OF THE REPORTED LEAKAGE CANNOT BE DETERMINED AT THIS TIME PENDING EVALUATION OF THE RETURNED SAMPLE. THE RETURN AND COMPLAINT RATES ARE LOW.

Description of Event or Problem

WHILE INSPECTING A PRODUCT DURING THE PACKING PROCESS, A TEAM MEMBER WAS EXPOSED TO A CHEMICAL THAT DRIPPED FROM THE BOTTOM OF THE PRODUCT ONTO HIS LEFT FOREARM. HE IMMEDIATELY WASHED THE AREA WITH SOAP AND WATER BUT SUBSEQUENTLY EXPERIENCED NUMBNESS, REDNESS, AND ITCHING. THE EMPLOYEE SOUGHT TREATMENT AT AN URGENT CARE FACILITY, WAS PRESCRIBED A TOPICAL CREAM FOR SKIN IRRITATION, AND WAS PLACED OFF WORK FOR TWO DAYS.