SONATA PUMP WARRANTY 1CT PT-B EN FR ES

Additional Manufacturer Narrative

THE CUSTOMER WAS SENT A REPLACEMENT PUMP, AND THE OLD PUMP WAS REQUESTED BACK FOR EVALUATION. FOLLOW UP WITH A COMPLAINT HANDLER TO THE CUSTOMER TO GET ADDITIONAL INFORMATION HAS GONE UNANSWERED AS OF THE DATE OF THIS REPORT. 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 THAT SHE WAS HAVING ISSUES WITH HER SONATA BREAST PUMP STAYING ON AND SHE WAS NOT ABLE TO PUMP. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS IN MAY AND WAS PRESCRIBED ANTIBIOTICS