TENDER CARE HYDROGEL PADS

Additional Manufacturer Narrative

CUSTOMER SERVICE REPLIED WITH AN RESPONSE, ENCOURAGING THE CUSTOMER TO MAKE CONTACT VIA PHONE SO THAT HER ISSUE COULD APPROPRIATELY BE ADDRESSED. IN FOLLOW UP BY A COMPLAINT HANDLER WITH THE CUSTOMER ON (B)(6) 2018, THE CUSTOMER RESPONDED THAT SHE STARTED USING THE GEL PADS 3 DAYS AFTER DELIVERY FOR IRRITATED NIPPLES FROM BREASTFEEDING. SHE STATED THAT SHE ONLY WORE THE GEL PADS FOR ABOUT 2 HOURS WHEN SHE NOTICED A BURNING SENSATION AND THEN SAW MARKS ON HER BREAST. SHE INDICATED THAT SHE STOPPED USING THE GEL PADS, VISITED HER LACTATION CONSULTANT (WHO CONSULTED HER OBGYN), AND WAS PRESCRIBED A COMPOUND STEROID CREAM. THE CUSTOMER INDICATED THAT THE BURNS ARE STILL NOTICEABLE, BUT ARE HEALING. SHE STATED THAT SHE HAS DISCARDED THE UNUSED 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.

Description of Event or Problem

ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT THE TENDER CARE HYDROGEL PADS BURNED HER SKIN TERRIBLY.