SWINGMAXI HANDSFREE PUMP EN ES FR

Additional Manufacturer Narrative

CUSTOMER SERVICE REPLACED THE CUSTOMER'S BREAST PUMP AND REQUESTED HER OLD PUMP BE RETURNED FOR TESTING/ANALYZING. ON (B)(6) 2026, THE CUSTOMER RESPONDED TO A COMPLAINT HANDLER. SHE STATED SHE HAD MASTITIS ON (B)(6) 2026 AND TOOK ANTIBIOTICS. HER NEW PUMP IS WORKING WELL SO FAR. HER MASTITIS HAS BEEN RESOLVED. THE DEVICE WAS RETURNED WITHOUT THE CUSTOMER'S PARTS AND ACCESSORIES; THEREFORE, IT WAS EVALUATED WITH A MEDELA LAB KIT ON 04/15/2026 AND IT PASSED SUCTION AND CYCLE SPECIFICATIONS. THE CUSTOMER'S REPORT OF LOW SUCTION COULD NOT BE CONFIRMED. 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 REACHED OUT TO MEDELA LLC VIA INSTAGRAM. SHE ALLEGED THAT HER SWING MAXI BREAST PUMP HAD LOW SUCTION AND THE PUMP WAS SHUTTING OFF AFTER 5 MIN. SHE ADDITIONALLY REPORTED THAT SHE HAD MASTITIS AND WAS PRESCRIBED ANTIBIOTICS BY HER HEALTHCARE PROVIDER.