SWING MAXI WARRANTY

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 WAS SENT A REPLACEMENT PUMP AND SHE HAD SENT HER PUMP IN FOR EVALUATION. ADDITIONALLY, THE CUSTOMER STATED SHE HAD DEVELOPED MASTITIS ON (B)(6) 2026 AND WAS PRESCRIBED ANTIBIOTICS. ON (B)(6) 2026 THE PUMP WAS EVALUATED AND TESTED WITH A MEDELA LAB KIT. THE DEVICE WAS FOUND TO HAVE RESIDUE IN THE AGGREGATE. BASED ON THE RESULTS OF OUR INTERNAL INVESTIGATION (B)(4) 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

(B)(6) 2026, THE CUSTOMER CALLED MEDELA LLC THAT WHILE USING THE SWING MAXI BREAST PUMP SHE EXPERIENCED ENGORGEMENT DUE TO POOR OR INSUFFICIENT EMPTYING OF HER BREASTS. ADDITIONALLY, ON (B)(6) 2026 THE CUSTOMER REPORTED THAT SHE HAD DEVELOPED MASTITIS REQUIRING ANTIBIOTICS.