BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE PRO TRADITIONAL EN ES

    MDR report key: 23592680 · Received November 19, 2025

    Report

    Report Number
    1419937-2025-00029
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    October 23, 2025
    Report Date
    January 8, 2026
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451470900
    PMA / PMN Number
    K200508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE SENT A REPLACEMENT PUMP AND REQUESTED THE PUMP BACK FOR TESTING. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2025, THE CUSTOMER STATED THAT SHE DEVELOPED MASTITIS ON (B)(6) 2025 AND IS ON HER SECOND ROUND OF ANTIBIOTICS NOW. THE CUSTOMER ALSO STATED THAT HER REPLACEMENT PUMP IS WORKING WELL. 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 (B)(6) 2013 TO (B)(6) 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

    CUSTOMER PUMP DOES NOT POWER ON WITH LAB OR CUSTOMER TRANSFORMER. CUSTOMER TRANSFORMER POWERS ON LAB PUMP. THE EVALUATION DETERMINED THAT THE PUMP HAD A DAMAGED DC JACK AND A DAMAGED PC BOARD.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE PRO BREAST PUMP CORD HAS TO BE HELD A CERTAIN WAY TO TURN THE PUMP ON DUE TO THE DC JACK BEING TILTED. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS AND WENT TO URGENT CARE AND WAS PRESCRIBED AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858899 PUMP IN STYLE PRO TRADITIONAL EN ES PUMP, BREAST, POWERED HGX MEDELA LLC 101047090 0000738886 00020451470900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other