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Patient 1
CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER AND THE CUSTOMER INDICATED THAT SUCTION WAS RESTORED. THE CUSTOMER WAS INSTRUCTED TO CALL BACK IF THE ISSUE RECURRED. ON (B)(6) 2019, THE CUSTOMER ALLEGED THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION AGAIN. THE CUSTOMER FURTHER ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC. CUSTOMER SERVICE ASKED THE CUSTOMER FOR PROOF OF PURCHASE TO REPLACE THE PUMP. THE CUSTOMER INDICATED THAT SHE WOULD CALL BACK AND PROVIDE IT. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 01/07/2020, THE CUSTOMER INDICATED THAT SHE DEVELOPED MASTITIS TWICE, BUT WAS NOT PRESCRIBED AN ANTIBIOTIC THE FIRST TIME. THE CUSTOMER INDICATED THAT THE SECOND TIME SHE DEVELOPED MASTITIS WAS AT THE BEGINNING OF (B)(6) 2019, FOR WHICH SHE HAD BEEN PRESCRIBED AN ANTIBIOTIC. THE CUSTOMER STATED THE MASTITIS WAS RESOLVED AND THAT SHE HAD A SECOND PUMP IN STYLE BREAST PUMP THAT SHE HAS BEEN USING SINCE THE MASTITIS. THE CUSTOMER INDICATED THAT SHE SENT IN A PROOF OF PURCHASE, BUT HAD NOT SPOKEN TO CUSTOMER SERVICE. THE COMPLAINT HANDLER TRANSFERRED THE CUSTOMER TO CUSTOMER SERVICE AND A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER. THE CUSTOMER WAS CONTACTED AGAIN BY A COMPLAINT HANDLER ON MULTIPLE OCCASIONS, INCLUDING IN WRITING, TO FOLLOW UP ON THE NEW PUMP AND RETURN OF THE OLD PUMP, WITH NO ADDITIONAL RESPONSE AS OF THE DATE OF THIS REPORT. BASED ON THE RESULTS OF CA11-001, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S MASTITIS. THE ESTIMATED INCIDENCE OF MASTITIS IN LACTATING WOMEN, WHETHER USING A BREAST PUMP OR NOT, ACCORDING TO PUBLISHED CLINICAL LITERATURE CAN BE AS HIGH AS 33%. IN FACT, CLINICAL GUIDELINES SUGGEST THE USE OF A BREAST PUMP TO FACILITATE WITHDRAWAL OF BREAST MILK DURING BOUTS OF MASTITIS. THE COMPLAINT RATE OF MASTITIS ACROSS ALL REPORTED FAILURES, ACROSS ALL MEDELA BREAST PUMPS, IS 0.008% FOR THE PERIOD OF (B)(6) 2013 TO (B)(6) 2017. MASTITIS IS USUALLY A BENIGN, SELF-LIMITING INFECTION WITH FEW CONSEQUENCES FOR THE SUCKLING INFANT. THE RISK OF MASTITIS IS HIGHER AMONG WOMEN WHO HAVE BREASTFED PREVIOUSLY, ESPECIALLY THOSE WITH A HISTORY OR MASTITIS." RIORDAN & WAMBACH, 4TH ED. P. 294: BREASTFEEDING AND HUMAN LACTATION. MASTITIS REQUIRES PROMPT MEDICAL ATTENTION FOR THE MOTHER FOR PAIN RELIEF AND PRESCRIPTION ANTIBIOTICS TO AVOID PROGRESSION TO OVERWHELMING SEPSIS.