PUMP IN STYLE HANDS-FREE RETAIL EN ES

Additional Manufacturer Narrative

CUSTOMER SERVICE SENT A REPLACEMENT PUMP TO THE CUSTOMER AND ASKED FOR THE RETURN OF HER OLD PUMP FOR EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2026, THE CUSTOMER STATED THAT SHE HAD DEVELOPED MASTITIS AND WAS PRESCRIBED ANTIBIOTICS. AT THIS TIME THE CUSTOMER HAS NOT RETURNED THEIR PUMP TO MEDELA LLC FOR EVALUATION. BASED ON THE RESULTS OF OUR INTERNAL INVESTIGATION (CAPA: 2025-0027) INCLUDING PUBLISHED LITERATURE, IT CANNOT DEFINITIVELY BE CONCLUDED THAT THE PUMP CAUSED OR HAS CONTRIBUTED TO THE CUSTOMER'S REPORTED MASTITIS. ACCORDING TO PUBLISHED CLINICAL LITERATURE, MASTITIS INCIDENCE IN LACTATING WOMEN, WITH OR WITHOUT A BREAST PUMP, CAN BE AS HIGH AS 33%. IN FACT, CLINICAL GUIDELINES RECOMMEND THE USE OF A BREAST PUMP TO FACILITATE THE REMOVAL OF BREAST MILK DURING PERIODS OF MASTITIS. ADDITIONALLY, COMPLAINT TRENDS ACROSS ALL MEDELA PUMPS SHOW MASTITIS INCIDENCE CONSISTENTLY BELOW 0.1%, FAR LOWER THAN THE 3-20% OCCURRENCE IN THE GENERAL POPULATION OF LACTATING WOMEN [2].

Description of Event or Problem

ON (B)(6) 2026, THE CUSTOMER ALLEGED TO MEDELA LLC WHILE USING HER PUMP IN STYLE HANDS-FREE BREAST PUMP, IT STOPPED SUCTIONING CAUSING CLOGGED DUCTS AND MASTITIS. ADDITIONALLY, ON (B)(6) 2026, THE CUSTOMER REPORTED THAT SHE REQUIRED ANTIBIOTICS FOR THEIR MASTITIS.