MINNCARE HD DISINFECTANT
Received Feb 23, 2024 · Event occurred Jan 24, 2024
Report 2150060-2024-00012 · MDR key 18770633
Device
Generic name
Disinfectant
Manufacturer
Medivators IncProduct problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Skin Discoloration
- Skin Discoloration
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THE EMPLOYEE IMMEDIATELY WASHED THEIR HANDS WITH SOAP AND WATER AFTER EXPOSURE. IT WAS NOT PROVIDED IF THE EMPLOYEE WAS WEARING PROPER PPE WHILE HANDLING THE DISINFECTANT. THE IFU STATES, "PERSONAL PROTECTIVE EQUIPMENT (PPE), HANDLERS MUST WEAR: GOGGLES OR FACE SHIELD, AND PROTECTIVE RUBBER GLOVES." STATEMENTS IN THE INSTRUCTIONS FOR USE: GIVE THE USER THE FOLLOWING CAUTIONS WHEN USING THE MINNCARE HD DISINFECTANT, "CORROSIVE. CAUSES IRREVERSIBLE EYE DAMAGE. HARMFUL IF ABSORBED THROUGH SKIN. DO NOT GET IN EYES, ON SKIN, OR ON CLOTHING. AVOID CONTACT WITH SKIN. PROLONGED OR FREQUENT REPEATED SKIN CONTACT MAY CAUSE AN ALLERGIC REACTION IN SOME INDIVIDUALS. WASH HANDS BEFORE EATING, DRINKING, CHEWING GUM, USING TOBACCO OR USING THE TOILET. REMOVE CONTAMINATED CLOTHING AND WASH HANDS BEFORE REUSE. CAUTION SHOULD BE USED WHEN APPLYING INDOORS BECAUSE PETS MAY BE AT RISK. IF IN EYES, HOLD EYE OPEN AND RINSE SLOWLY AND GENTLY WITH WATER FOR 15-20 MINUTES. REMOVE CONTACT LENSES, IF PRESENT, AFTER FIRST 5 MINUTES, THEN CONTINUE RINSING. CALL A POISON CONTROL CENTER OR DOCTOR FOR TREATMENT ADVICE." STERIS HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE SUBJECT EVENT HOWEVER, THE USER FACILITY HAS NOT RESPONDED. WITHOUT FURTHER INFORMATION THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. NO OTHER ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT AN EMPLOYEE OBTAINED SKIN DISCOLORATION TO THEIR LEFT THUMB AND "SLIGHT PAIN" WHILE USING MINNCARE HIGH-LEVEL DISINFECTANT. MEDICAL TREATMENT WAS SOUGHT, BUT IT WAS NOT DISCLOSED IF MEDICAL TREATMENT WAS ADMINISTERED.