BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE HANDS-FREE EN ES FR - US ADAPTER

    MDR report key: 22069583 · Received May 22, 2025

    Report

    Report Number
    1419937-2025-00011
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    May 6, 2025
    Report Date
    June 6, 2025
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    UDI-DI
    00020451441641
    PMA / PMN Number
    K191653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE CONDUCTED SOME TROUBLESHOOTING WITH THE CUSTOMER. A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER, AND THE OLD PUMP WAS REQUESTED BACK FOR EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2025, THE CUSTOMER STATED THAT SHE HAS A FOLLOW-UP WITH HER DOCTOR BECAUSE HER RIGHT BREAST THAT HAD MASTITIS STILL SEEMS BLOCKED/KNOTTED. THE CUSTOMER STATED THAT SHE TRIED TO USE THE NEW PUMP SENT AND NOTHING MUCH CAME OUT. THE PUMP IS WORKING WAY BETTER THAN THE PREVIOUS PUMP. IT'S NOT LOSING/LOW SUCTION OR FREEZING. I'VE BEEN USING THE MEDELA HAND PUMP RIGHT NOW AND IT'S GETTING THE MILK OUT. BASED ON THE RESULTS OF OUR INTERNAL INVESTIGATION (REFERENCE NUMBER (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 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 OF MASTITIS. RIORDAN & WAMBACH, 4TH ED. P. 294: BREASTFEEDING AND HUMAN LACTATION. HOWEVER, IN THIS CASE, THE MOTHER¿S MASTITIS REQUIRED PROMPT MEDICAL ATTENTION FOR PAIN RELIEF AND PRESCRIPTION ANTIBIOTICS TO AVOID PROGRESSION TO OVERWHELMING SEPSIS.

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RETURNED AND EVALUATED ON 6/5/2025, THE EVALUATION DETERMINED THAT THE PUMP EXHIBITED INTERMITTED OPERATION. THE EVALUATION FOUND ONE OF THE WIRES CONNECTED TO THE MOTOR WAS DAMAGED/BROKEN.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE HANDS FREE BREAST PUMP SUCTION FELT OFF. THE CUSTOMER ALSO ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261403 FREESTYLE HANDS-FREE EN ES FR - US ADAPTER PUMP, BREAST, POWERED HGX MEDELA AG 101044164 0000711634 00020451441641

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other