BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE HANDS-FREE RETAIL EN ES

    MDR report key: 23826259 · Received December 17, 2025

    Report

    Report Number
    1419937-2025-00031
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 17, 2025
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451454368
    PMA / PMN Number
    K200508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE SENT THE CUSTOMER A REPLACEMENT PUMP AND REQUESTED THAT THEIR OLD PUMP AND PARTS BE RETURNED TO MEDELA FOR TESTING/ANALYZING. THE CUSTOMER WAS CONTACTED BY A COMPLAINT HANDLER ON MULTIPLE OCCASIONS, TO GET ADDITIONAL INFORMATION, WITH NO RESPONSE AS OF THE DATE OF THIS REPORT. THE DEVICE WAS RETURNED WITHOUT THE CUSTOMER'S PARTS; THEREFORE, IT WAS EVALUATED WITH A MEDELA LAB KIT ON 12/16/2025 AND RESIDUE WAS FOUND ON THE AGGREGATE. IT PASSED SUCTION SPECIFICATIONS AFTER CLEANING THE AGGREGATE. THE PUMP POWERED ON WITH MEDELA LAB TRANSFORMER AND CUSTOMER'S TRANSFORMER AND BATTERY PACK WITH MEDELA LAB BATTERIES. THE CUSTOMER'S REPORT OF LOW SUCTION AND POWER ISSUE COULD NOT BE CONFIRMED. 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 (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 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.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THEIR PUMP IN STYLE HANDS FREE BREAST PUMP WAS HURTING THEIR NIPPLES, AND THE PUMP WAS HAVING POWER ISSUES. THE CUSTOMER ADDITIONAL ALLEGED THEY DEVELOPED MASTITIS DUE TO THE PUMP NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181940 PUMP IN STYLE HANDS-FREE RETAIL EN ES PUMP, BREAST, POWERED HGX MEDELA LLC 101045436 0000740381 00020451454368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other