IN FOLLOW UP WITH THE CUSTOMER ON (B)(6) 2017, THE CUSTOMER RESPONDED THAT SHE MAY HAVE AN ALLERGY TO ONE OF THE INGREDIENTS IN THE HYDROGEL PADS THAT SHE DIDN'T KNOW ABOUT, AND WILL HAVE TO AVOID COMING IN CONTACT WITH IT IN THE FUTURE. SHE INDICATED THAT SHE WAS PRESCRIBED AN ANTIBIOTIC AND STOPPED USING THE HYDROGEL PADS IMMEDIATELY, THOUGH THE PRODUCT WAS VERY HELPFUL IN DOING WHAT IT WAS DESIGNED TO DO, BUT JUST DIDN'T WORK WITH HER SENSITIVE SKIN. SHE STATED THAT SHE DISCARDED THE PRODUCT. REPORTED ISSUES OF RASH RELATED TO THE HYDROGEL PADS WERE INVESTIGATED UNDER (B)(4), WHICH DETERMINED THE PROBABLE ROOT CAUSES TO BE (1) CUSTOMERS WITH GLYCERIN ALLERGIES EXPERIENCING AGGRESSIVE IMMUNE REACTIONS DUE TO THE FACT THAT GLYCERIN IS AN INTEGRAL INGREDIENT IN THE HYDROGEL PADS AND (2) PATHOGENS OR ALLERGENS THAT COME IN CONTACT WITH EXPOSED HYDROGEL PADS WHICH WOULD SUBSEQUENTLY BE INTRODUCED TO THE USER?S BREAST.
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Patient 1
ON (B)(6) 2017, THE CUSTOMER ALLEGED VIA EMAIL TO MEDELA LLC THAT SHE USED THE TENDER CARE HYDROGEL PADS FOR THE FIRST TIME AND EXPERIENCED A SEVERE ALLERGIC REACTION. THE PRODUCT WORKED WELL AT FIRST UNTIL HER ENTIRE BREASTS BECAME COVERED IN HIVES, SWOLLEN AND RED ALL OVER. TO HER KNOWLEDGE, SHE DIDN'T HAVE ALLERGIES TO THE LISTED INGREDIENTS, BUT DID INDICATE AN ALLERGY TO LATEX. SHE WANTED TO KNOW IF THERE WAS ANY LATEX IN THE PRODUCT; OTHERWISE, SHE MAY HAVE DISCOVERED ANOTHER ALLERGY.