ELECSYS SYSCLEAN

Description of Event or Problem

THE CUSTOMER WAS INJURED WHEN THE SYSCLEAN SOLUTION SPLASHED ONTO HER FACE. SHE WAS STARTING MAINTENANCE AND WAS PREPARING TO PUT THE SYSCLEAN INTO A MICROCUP. SHE WIPED THE TIP OF THE SYSCLEAN SQUIRT BOTTLE AND THEN SQUIRTED THE SYSCLEAN UPSIDE DOWN AND AT AN ANGLE INTO THE CUP. THE TIP CAME OFF OF THE BOTTLE AND THE SYSCLEAN SPLASHED UP. THE CUSTOMER TURNED HER HEAD AND THE SOLUTION HIT THE SIDE OF HER FACE AND RAN DOWN TOWARDS HER NECK. THE CUSTOMER GRABBED SOME PAPER TOWELS AND THEN WENT TO A SINK AND RAN WATER ON IT HER FACE FOR ABOUT 10 MINUTES. IT WAS STILL BURNING AFTER THE 10 MINUTES SO SHE RINSED IT FOR 20 MINUTES MORE. SHE STATED IT WAS STILL REALLY BURNING, SO SHE WENT TO THE ER. BY THE TIME SHE GOT TO THE ER, SHE HAD THE OPEN SORE ON HER FACE. THE CUSTOMER WAS GIVEN KEFLEX AND A CREAM TO KEEP HER SKIN MOIST. ON (B)(6) 2012, THE CUSTOMER WAS EXAMINED BY A PLASTIC SURGEON. THE PLASTIC SURGEON DEBRIDED THE AREA AND PRESCRIBED ANTIBIOTICS AS HE THOUGHT IT MIGHT BE INFECTED. THE LOT NUMBER OF THE SYSCLEAN SOLUTION WAS NOT PROVIDED. THE BOTTLE WAS DISPOSED OF AFTER THE INCIDENT. THE ONLY PERSONAL PROTECTIVE EQUIPMENT BEING WORN BY THE CUSTOMER WAS GLOVES. NO GLASSES OR LAB COAT WERE WORN.

Additional Manufacturer Narrative

NO OTHER COMPLAINTS HAVE BEEN RECEIVED REGARDING THE TIP COMING OFF OF A SYSCLEAN BOTTLE. THIS SHOWS THE ISSUE COULD NOT HAVE BEEN CAUSED BY A GENERAL OR LOT SPECIFIC DEFECT OF THE BOTTLE. PRODUCT LABELING INSTRUCTS THE USER TO WEAR SUITABLE PROTECTIVE CLOTHING, GLOVES AND EYE/FACE PROTECTION.

Additional Manufacturer Narrative

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

Additional Manufacturer Narrative

THE PRECAUTIONS AND WARNINGS SECTION OF THE PRODUCT LABELING HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION FOR THE CUSTOMER.