BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BREAST PUMP - SINGLE

    MDR report key: 7686806 · Received July 13, 2018

    Report

    Report Number
    1419937-2018-00160
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    May 17, 2018
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K150499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PROVIDED TROUBLESHOOTING TIPS VIA EMAIL FROM MEDELA CUSTOMER SERVICE AND INSTRUCTED TO CALL IF THEY DID NOT RESOLVE HER ISSUE. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 07/07/2018, THE CUSTOMER CONFIRMED THAT SHE DEVELOPED MASTITIS AND INDICATED THAT SHE WAS PRESCRIBED AN ANTIBIOTIC. THE CUSTOMER INDICATED THAT THE MASTITIS IS RESOLVED, THAT SHE CAUTIOUSLY USES THE FREESTYLE BREAST PUMP, AS SHE CAN FEEL PLUGGED DUCTS STARTING, AND THAT SHE HAS NO SUCH ISSUES WHEN USING HER PUMP IN STYLE BREAST PUMP. CONTACT WITH THE CUSTOMER IS ON-GOING TO DETERMINE IF THE ISSUE WITH THE PUMP WAS RESOLVED WITH THE TROUBLESHOOTING TIPS. 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 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 · 1

    ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT SHE WAS LOSING SUCTION ON HER FREESTYLE BREAST PUMP. SHE ALLEGED THAT SHE WAS HAVING TO UNSNAP AND RECONNECT THE CONNECTORS MULTIPLE TIMES IN ORDER TO GET ADEQUATE SUCTION. ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT SHE NEEDED REPLACEMENT MEMBRANES FOR HER FREESTYLE BREAST PUMP. THE CUSTOMER ALLEGED THAT SHE HAD EXPERIENCED MASTITIS AND BELIEVES IT WAS FROM THE PUMP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526707 FREESTYLE BREAST PUMP - SINGLE PUMP, BREAST, POWERED HGX MEDELA AG 101034712 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other