SWING MAXI PUMP & HF COLLECTION CUPS

Additional Manufacturer Narrative

CUSTOMER SERVICE SENT A REPLACEMENT PUMP TO THE CUSTOMER AND ASKED FOR THE RETURN OF HER OLD PUMP FOR EVALUATION. THE CUSTOMER'S PUMP WAS EVALUATED ON (B)(6) 2026, THE PUMP POWERS ON BUT DOES NOT RUN. WHEN THE POWER BUTTON IS PRESSED PUMP POWERS OFF. UNABLE TO PERFORM VACUUM TEST DUE TO PUMP NOT FUNCTIONING PROPERLY. THE CUSTOMER WAS CONTACTED BY COMPLAINT HANDLER ON MULTIPLE OCCASION, WITH NO RESPONSE AS OF THE DATE OF THIS REPORT. 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 HER SWING MAXI BREAST PUMP WOULD NOT POWER ON. ON (B)(6) 2026, THE CUSTOMER CALLED BACK DUE TO NOT GETTING HER REPLACEMENT BREAST PUMP AND ALLEGED THAT SHE DEVELOPED MASTITIS FOR WHICH SHE WAS PRESCRIBED AN ANTIBIOTIC.