PATTERSON CHLOROPRENE EXAMINATION GLOVES ¿ POWDER FREE, LATEX FREE, 200/BOX

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 3/25/24 FOR REPORT MW5115988. NEW: REFERENCE MW5115988: THIS IS AN UPDATE TO AN EXISTING MDR TO ADD INFORMATION THAT WAS OBTAINED FOLLOWING THE ORIGINAL SUBMISSION. NEW INFORMATION WILL BE PRECEDED WITH "NEW" TO IDENTIFY NEW INFORMATION BEING ADDED TO THE REPORT. PROBLEM: SEVERAL HYGIENISTS HAVE BEEN EXPERIENCING SEVERE RASHES ON THEIR HANDS FROM THE PATTERSON CHLOROPRENE GLOVES. INVESTIGATION RESULTS: AFTER CONDUCTING A THOROUGH INVESTIGATION AND ANALYSIS OF THE RETAINED SAMPLES OF THE COMPLAINT LOTS, WE HAVE CONCLUDED THAT THE GLOVES CONFORM TO THE NORMAL REQUIREMENTS. NO ABNORMALITIES WERE DETECTED THAT COULD LEAD TO SKIN ALLERGY OR RASH. FURTHERMORE, NO CHANGES HAVE BEEN MADE TO THE MANUFACTURING PROCESS OR FORMULATION OF THE GLOVES. CHEMICAL EXTRACTION TESTING WAS ALSO INITIATED ON THE RETAINED SAMPLES, AND THE RESULTS WERE COMPARABLE WITH THE CONTROL SAMPLES. IT IS OUR ASSUMPTION THAT THE MILD REACTION EXPERIENCED BY THE AFFECTED INDIVIDUAL IS DUE TO THE ACCELERATORS PRESENT IN THE GLOVES. ALTHOUGH THESE ACCELERATORS ARE USED IN THE MAJORITY OF NATURAL RUBBER, NITRILE SYNTHETIC, AND CHLOROPRENE SYNTHETIC GLOVES, THEY CAN CAUSE TYPE IV (DELAYED TYPE) ALLERGY REACTIONS IN A SMALL PERCENTAGE OF USERS. WE WOULD RECOMMEND THAT THE AFFECTED INDIVIDUAL BE PATCH TESTED BY A DERMATOLOGIST OR ALLERGIST TO DETERMINE THE EXACT CAUSE OF THE REACTION. IF ACCELERATOR CHEMICALS ARE RESPONSIBLE, IT IS LIKELY THAT THEY WILL CONTINUE TO EXPERIENCE DIFFICULTIES. IN ADDITION TO THE POTENTIAL ALLERGY CAUSED BY THE ACCELERATORS IN THE GLOVES, IT IS ALSO POSSIBLE THAT THE REACTION WAS DUE TO ANOTHER SOURCE. CHEMICALS FROM DETERGENTS, COLD STERILANT, ETC., THAT ARE NOT FULLY RINSED OFF CAN LEAVE RESIDUES ON THE SKIN AND CAUSE A TEMPORARY SKIN REACTION. MOREOVER, CONSTANT CYCLING OF GLOVING AND HAND WASHING, PARTICULARLY DURING THE COLD WINTER MONTHS, IS ONE OF THE MOST COMMON SOURCES OF HAND IRRITATION IN HEALTHCARE. FREQUENT HAND WASHING ALONE CAN WEAKEN THE SKIN'S NATURAL BARRIERS, MAKING IT MORE VULNERABLE TO DERMATITIS ISSUES. THEREFORE, WE RECOMMEND THAT INDIVIDUALS WHO EXPERIENCE SKIN REACTIONS SHOULD TAKE EXTRA PRECAUTIONS TO PROTECT THEIR SKIN, SUCH AS USING MOISTURIZING CREAMS AND MINIMIZING EXPOSURE TO POTENTIAL IRRITANTS.

Description of Event or Problem

FEW GIRLS ARE BREAKING OUT IN RASHES ON THEIR HANDS.