Description of Event or Problem · 0
I'VE BEEN USING MEDPRIDE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVES FROM SHIELD LINE LLC FOR OVER A YEAR AT THIS POINT AND HAVE HAD NO ISSUES. HOWEVER, I RECEIVED A SPECIFIC LOT THAT SEEMS TO BE CONTAMINATED WITH FIBERGLASS PARTICLES. AFTER A FEW DAYS OF USAGE, I NOTICED SEVERE RASHES ALL OVER MY BODY. UPON FURTHER INVESTIGATION, I FOUND THAT THE GLOVES HAD SHINY PARTICLES ALL OVER THEM. I PUT A PIECE OF GLOVE UNDER A MICROSCOPE AND SAW CLEAR FILAMENTS COVERING THEM WHICH I ASSUME IS FIBERGLASS. I ALSO HAD A BRAND NEW BOX OF GLOVES FROM THIS SAME LOT AND IT TOO WAS COVERED IN THESE PARTICLES. I WENT TO URGENT CARE AND WAS DIAGNOSED WITH CONTACT DERMATITIS. LIKE STATED PREVIOUSLY, I HAVE USED THESE GLOVES FOR OVER A YEAR WITHOUT ISSUE AND EVEN WORK IN A LAB USING NITRILE GLOVES DAILY SO THIS WAS NOT AN ISSUE OF AN ALLERGIC REACTION TO THE GLOVE MATERIAL ITSELF. I ALSO PURCHASED ANOTHER BOX OF THESE GLOVES FROM A DIFFERENT LOT AND SAW NO SUCH PARTICLES ON THE GLOVES. THE PARTICLES HAVE CONTAMINATED MY BEDDING, CLOTHING, AND FURNITURE. I REACHED OUT TO SHIELD LINE LLC TO DISCUSS THE DEFECTIVE PRODUCT AND WAS DISMISSED WITH THEM ESSENTIALLY SAYING "WE'VE NEVER HEARD THIS COMPLAINT BEFORE, THERE'S NOTHING WE CAN DO" WITHOUT ASKING ABOUT LOT NUMBERS OR ANY OTHER INFORMATION ABOUT THE ISSUE. THEY THEN REFERRED ME TO AMAZON WHICH IS WHERE I PURCHASED THE PRODUCT. I HAVE MORE IMAGES OF THE CONTAMINATED GLOVES BUT WAS RESTRICTED BY THE UPLOAD FILE SIZE LIMIT. HEALTH EFFECT CODE: 4546. DEVICE PROBLEM CODE: 1120, 2588. REFERENCE REPORT: MW5175052. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).