BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS AVENT DOUBLE ELECTRIC BREAST PUMP ADVANCED

    MDR report key: 17874936 · Received October 5, 2023

    Report

    Report Number
    3010359222-2023-00018
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    September 14, 2023
    Report Date
    October 3, 2023
    Manufacturer
    PAYER INDUSTRIES HUNGARY
    Product Code
    HGX
    PMA / PMN Number
    K203383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OCTOBER 31ST 2023 UPDATE: CONSUMER HAS INFORMED PHILIPS THAT AFTER TREATMENT IT WAS DETERMINED SHE HAD TOO MUCH MILK. CONSUMER IS CURRENTLY USING THE DEVICE WITHOUT PROBLEM. THE DEVICE IS THEREFORE NOT AVAILABLE FOR TECHNICAL INVESTIGATION. H3 OTHER TEXT : REMAINED AT CONSUMER.

    Description of Event or Problem · 0

    CONSUMER REPORTS THAT THE EXPRESSION KIT OF THE BREAST PUMP DOES NOT FIT PROPERLY, IT CAUSES HER PAIN. SHE ALSO ALLEGES THAT SHE GOT MASTITIS. OCTOBER 31ST 2023 UPDATE: CONSUMER HAS INFORMED PHILIPS THAT AFTER TREATMENT IT WAS DETERMINED SHE HAD TOO MUCH MILK. CONSUMER IS CURRENTLY USING THE DEVICE WITHOUT PROBLEM. THE DEVICE IS THEREFORE NOT AVAILABLE FOR TECHNICAL INVESTIGATION.

    Description of Event or Problem · 0

    CONSUMER REPORTS THAT THE EXPRESSION KIT OF THE BREAST PUMP DOES NOT FIT PROPERLY, IT CAUSES HER PAIN. SHE ALSO ALLEGES THAT SHE GOT MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342769 PHILIPS AVENT DOUBLE ELECTRIC BREAST PUMP ADVANCED POWERED BREAST PUMP HGX PAYER INDUSTRIES HUNGARY SCF392/11

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other