BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 9769282 · Received February 28, 2020

    Report

    Report Number
    1419937-2020-00015
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    February 1, 2020
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K191653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT REPLACEMENT PARTS AND ACCESSORIES. ON 02/05/2020, THE CUSTOMER CALLED BACK AND ALLEGED TO MEDELA LLC THAT HER FREESTYLE FLEX BREAST PUMP WOULD NOT TURN ON, SO SHE RENTED ANOTHER PUMP TO USE. BECAUSE SHE WAS NOT ABLE TO BE MOBILE WITH THE RENTED PUMP, SHE PUMPED LESS OFTEN, CAUSING HER TO GET MASTITIS, FOR WHICH SHE STARTED ANTIBIOTICS ON (B)(6) 2020. THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 02/14/2020, THE CUSTOMER INDICATED THAT THE REPLACEMENT PUMP WAS WORKING WITHOUT ISSUE AND THE MASTITIS WAS RESOLVED. 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 01/30/2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THERE WAS A MILK BACKUP WHEN USING HER FREESTYLE FLEX BREAST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231704 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 160120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other