NIPPLE SHIELD

Additional Manufacturer Narrative

IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2018, THE CUSTOMER CONFIRMED THAT SHE DEVELOPED MASTITIS AROUND (B)(6) 2018 AND WAS PRESCRIBED AN ANTIBIOTIC, BUT THAT AT THE TIME SHE WAS NOT USING THE PUMP IN STYLE BREAST PUMP, BUT WAS USING MEDELA NIPPLE SHIELDS, DUE TO A LATCH ISSUE. THE CUSTOMER INDICATED THAT SHE HAS HAD TWO ULTRASOUNDS AND STILL HAS MASTITIS WITH NO DRAINABLE ABSCESS, AS THE INFECTION IS BROKEN UP INTO MULTIPLE SMALL AREAS THAT CANNOT BE EFFECTIVELY DRAINED. SHE CONTINUES TO HAVE A 4MM LUMP IN HER RIGHT BREAST, BUT IS WORKING WITH HER DOCTOR AND A LACTATION NURSE TO RESOLVE THE ISSUE. FOLLOW UP WITH MEDELA CLINICAL IS ONGOING. BASED ON THE RESULTS OF (B)(4), 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 (B)(4)% FOR THE PERIOD OF JANUARY 2013 TO AUGUST 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.

Description of Event or Problem

ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA (B)(4) VIA EMAIL THAT THE SUCTION ON A BORROWED PUMP IN STYLE BREAST PUMP WAS LOW DUE TO EXCESS AIR BEING PULLED THROUGH THE PORT ON HER FACEPLATE. THE CUSTOMER ALSO ALLEGED THAT SHE HAD MASTITIS, FOR WHICH SHE WAS PRESCRIBED AN ANTIBIOTIC.

Additional Manufacturer Narrative

IN FOLLOW UP WITH A MEDELA CLINICIAN ON (B)(6) 2018, THE CUSTOMER INDICATED THAT SHE IS GOING THROUGH ULTRASOUND TREATMENTS FOR CONTINUED MASTITIS. THE MEDELA CLINICIAN DISCUSSED TIPS FOR BREAST HEALING, INCLUDING USE OF EPSOM SALT SOAKS AND LECITHIN. THE CUSTOMER INDICATED THAT SHE STARTED LEAKING AT 19 WEEKS' PREGNANCY AND STATED THAT SHE NOTED BREAST PAIN AT THE END OF HER PREGNANCY, BEFORE SHE HAD THE BABY AND STARTED PUMPING. THE CUSTOMER INDICATED THAT HER BABY NURSES ON THE LEFT SIDE, BUT DUE TO A DECREASED MILK SUPPLY WITH THE MASTITIS, SHE DOES NOT NURSE ON THE RIGHT FOR VERY LONG. THE CUSTOMER IS NOW GETTING 10ML FROM THE RIGHT AND HER BABY IS GAINING WEIGHT WHILE NURSING ON THE LEFT SIDE ONLY. THE CUSTOMER IS WORKING WITH A LOCAL LACTATION CONSULTANT AND DOCTOR. THE MEDELA CLINICIAN SENT EMAIL WITH TIPS FOR EFFECTIVE PUMPING AND THE CUSTOMER INDICATED THAT SHE WOULD FOLLOW UP ON 07/10/2018 WITH A MASTITIS UPDATE, AFTER A DOCTOR APPOINTMENT ON (B)(6) 2018. THE CUSTOMER INDICATED THAT HER PUMP WAS WORKING WELL. IN FOLLOW UP WITH A MEDELA CLINICIAN ON (B)(6) 2018, THE CUSTOMER INDICATED THAT DURING HER LACTATION APPOINTMENT ON (B)(6) 2018, HER NURSE WAS VERY CONCERNED ABOUT HOW MUCH REDNESS SHE STILL HAD AND THE SIZE OF THE MASS. THE CUSTOMER INDICATED THAT SHE WAS HAVING HER POST-PARTUM CHECK UP AFTERWARDS AT THE SAME OFFICE, SO SHE CONTACTED HER DOCTOR, AT WHICH POINT HER APPOINTMENT WAS CHANGED FROM POST-PARTUM TO A CONSULT FOR CHRONIC MASTITIS. THE CUSTOMER SAW THE OB WHO WAS ON CALL FOR THE HOSPITAL AND SHE CALLED TO ARRANGE TO HAVE HER ADMITTED TO THE HOSPITAL. THE CUSTOMER WAS IMMEDIATELY GIVEN ANTIBIOTICS VIA IV, MILK CULTURES WERE TAKEN, TWO ULTRA SOUNDS WERE ADMINISTERED AND EVENTUALLY, SHE HAD TO HAVE LIQUID ASPIRATED FROM ONE OF THE AREAS THEY WERE QUESTIONING IN HER BREAST. THE LIQUID WAS A PUSS/MILK MIXTURE AND ULTIMATELY THE CULTURE CAME BACK AS POSITIVE FOR MRSA, EVEN THOUGH ALL OTHER TESTS/CULTURES, AND EVEN A NOSE SWAB, DIDN'T SHOW MRSA. THE CUSTOMER INDICATED THAT SHE SAW A COUPLE OF GENERAL SURGEONS, ALL WHO AGREED THAT SHE SHOULD NOT GET SURGICAL ASPIRATION DUE TO THE RISK OF A MILK FISTULA. THE AREAS OF ABSCESS WERE ALSO TOO SMALL TO TRY TO ASPIRATE. DURING THAT TIME, THEY SWITCHED HER TO AN ANTIBIOTIC THAT WOULD BE LESS HARSH ON HER VEINS, BUT SINCE IT WAS NEWER, THE PHARMACIST SUGGESTED SHE PUMP AND DUMP SO SHE GAVE HER BABY FORMULA FOR ABOUT ONE DAY AND A HALF. THE CUSTOMER INDICATED THAT WAS VERY UPSET ABOUT HAVING TO PUMP AND DUMP, BUT THE INFECTIOUS DISEASE SPECIALIST ARRANGED FOR HER TO GET A PICC LINE SO SHE COULD GO BACK TO THE PREVIOUS ANTIBIOTIC. THE CUSTOMER WAS IN THE HOSPITAL FROM APPROXIMATELY (B)(6) 2018 AND HER INFECTIOUS DISEASE SPECIALIST GAVE THE ALL CLEAR FOR HER TO LEAVE THE HOSPITAL AND DO AT HOME ANTIBIOTIC IV INFUSIONS. THE CUSTOMER INDICATED SHE IS STILL DOING THE IV INFUSIONS AT LEAST UNTIL (B)(6) 2018, IF NOT LONGER. THE PAIN IS ALMOST GONE, THE MASS AND REDNESS HAVE DECREASED IN SIZE SIGNIFICANTLY, BUT SO HAS HER MILK SUPPLY ON THE RIGHT SIDE AND SHE IS HOPING THAT THE LEFT BREAST CAN KEEP UP.