BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDELA PUMP IN STYLE ADVANCED BREAST PUMP

    MDR report key: 2041194 · Received March 29, 2011

    Report

    Report Number
    1419937-2011-00047
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    January 30, 2011
    Report Date
    February 1, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER, THOUGH SHE IS SENDING IT BACK AND WILL CONTINUE TO USE THE HOSPITAL-GRADE PUMP. IN F/U WITH THE CUSTOMER ON (B)(6) 2011, SHE STATED SHE HAD BEEN USING THE PUMP SINCE HER BABY WAS BORN AND ENDED UP DEVELOPING MASTITIS AND A YEAST INFECTION. SHE HAD CONTINUED PUMPING ON THE LOWEST SETTING AND HER NIPPLES WOULDN'T HEAL (SEVERAL BLOOD BLISTERS). SHE STATED SHE DEALT WITH IT FOR SIX WEEKS, THEN WENT THROUGH ROUNDS OF ANTIBIOTICS PRESCRIBED BY HER PHYSICIAN (NYSTATIN AND DIFLUCAN). A LACTATION CONSULTANT RECOMMENDED A DIFFERENT HOSPITAL-GRADE PUMP (SYMPHONY), AND HER NIPPLES HEALED RIGHT UP, EVEN THOUGH SHE WAS PUMPING THE SAME AMOUNT. SHE HAD TRIED ALL DIFFERENT BREAST SHIELD SIZES FOR BOTH THE PUMP IN STYLE AND SYMPHONY; SHE TRIED LANOLIN AND SOFTFIT BREAST SHIELDS. SHE STATED THE PUMP IN STYLE DID NOT RELIEVE HER ENGORGEMENT AND THE SUCTION WAS TOO STRONG. A CLINICAL REVIEW OF THE INFORMATION ON (B)(6) 2011 WAS PERFORMED AND CONCLUDED NO PERMANENT ADVERSE EFFECTS TO THE CUSTOMER. A DECISION WAS MADE ON (B)(6) 2011, BASED ON THE INFORMATION AND STANDARDS AT THAT TIME, THAT THE EVENT DID NOT REQUIRE A MEDWATCH SUBMISSION. THE ORIGINAL PUMP WAS RETURNED FOR EVALUATION ON (B)(6) 2011. TESTING WAS CONDUCTED ON (B)(6) 2011. THE VACUUM LEVELS AND CYCLE RATES WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS (SEE SCANNED TABLE). WHILE IT CANNOT BE CONFIRMED WHETHER OR NOT THE PUMP DIRECTLY CAUSED THE CUSTOMER'S REPORTED ISSUES, MASTITIS IS CONSIDERED A SERIOUS INJURY AND, BASED ON CURRENT STANDARDS, THEREFORE REPORTABLE. EVALUATION SUMMARY: THE RETURNED PUMP WAS TESTED AGAINST VACUUM AND CYCLE RATE PERFORMANCE SPECIFICATIONS. VACUUM RATES WERE MEASURED USING A KEYENCE GAUGE; CYCLE RATES WERE MEASURED BY COUNTING THE NUMBER OF CYCLES OVER A ONE MINUTE PERIOD AS MEASURED BY A STOP WATCH. THE PUMP WAS ALLOWED TO RUN FOR 30 SECONDS PRIOR TO MEASUREMENTS BEING TAKEN. THE PRODUCT FUNCTIONED PROPERLY THROUGHOUT THE TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, "I HAVE BEEN USING THE PUMP IN STYLE PUMP FOR ABOUT SIX WEEKS NOW. I HAVE HAD MANY PROBLEMS SUCH AS RAW, SORE NIPPLE(S) FOR SIX WEEKS NOW AND IT IS DUE TO THIS PUMP. I USED THE PUMP FOR SIX WEEKS ON THE LOWEST SETTING IT HAS FOR 15 MINUTES EVERY THREE HOURS AND MY NIPPLES ARE BLOODY AND RAW. I HAVE ALSO HAD MASTITIS TWICE. I HAVE BOUGHT ABOUT EVERY PRODUCT (B)(6) MAKES TO TRY TO SOLVE MY PROBLEMS (SUCH AS BIGGER FLANGES, SOFT FIT FLANGES, ETC). I WAS STILL HAVING PROBLEMS WITH SORE RAW NIPPLES, SO I CONTACTED A LACTATION CONSULTANT AND SHE LET ME RENT THE SYMPHONY FROM THE HOSPITAL. MY NIPPLES HAVE HEALED SINCE I HAVE BEEN USING THE SYMPHONY PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDELA PUMP IN STYLE ADVANCED BREAST PUMP HGX MEDELA, INC. 57027

    Patients

    Seq Age Sex Outcome Treatment
    1 Other