BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS AVENT MANUAL BREAST PUMP

    MDR report key: 22920702 · Received August 29, 2025

    Report

    Report Number
    3010359222-2025-000003
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 14, 2025
    Report Date
    December 3, 2025
    Manufacturer
    PAYER INDUSTRIES HUNGARY
    Product Code
    HGY
    UDI-DI
    00075020109453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DECEMBER 2ND 2025 UPDATE: THE DEVICE WAS RETURNED AND TESTED. IT WAS FOUND WORKING ACCORDING TO SPECIFICATIONS. THE CUSTOMER REPORTS USING THE MANUAL BREAST PUMP APPROXIMATELY 10 TIMES FOR SESSIONS OF ABOUT 15 MINUTES, AS SHE OTHERWISE BREASTFEEDS ALMOST EXCLUSIVELY. SHE APPLIES THE PUMP BY PLACING THE BREAST INTO IT. DURING USE, SHE EXPERIENCED A SHARP PULLING PAIN IN THE NIPPLE, AND AFTER A PUMPING SESSION DEVELOPED A VERY SORE, RED AREA ON THE BREAST WITH A PAINFUL LUMP. SHE WAS DIAGNOSED WITH MASTITIS BY HER DOCTOR. THE NIPPLE ALSO DEVELOPED A BLEB. BLEB FORMATION CAN BE ATTRIBUTABLE TO THE USER PLACING HER BREAST IN PUMP, WHILE THE INSTRUCTION FOR USE RECOMMENDS TO PRESS THE PUMP AGAINST THE BREAST. PLACING THE BREAST IN THE PUMP CAN CAUSE THAT THE EXPRESSION KIT IS NOT CENTERED IN THE NIPPLE. THIS COULD LEAD TO TEMPORARY DISCOMFORT (SUCH AS NIPPLE BLEBS); IT IS UNLIKELY THAT THIS SCENARIO LEADS TO MASTITIS WITHIN SUCH A SHORT TIME FRAME (RIGHT AFTER A PUMPING SESSION IN THIS CASE). CUSTOMER IS EXCLUSIVELY BREASTFEEDING. MASTITIS IS A COMMON CONDITION AMONG BREASTFEEDING MOTHERS, WITH A PREVALENCE OF UP TO 30%.

    Description of Event or Problem · 0

    CUSTOMER CLAIMS THAT THE MANUAL BREAST PUMP CAUSED MASTITIS.

    Description of Event or Problem · 0

    CUSTOMER CLAIMS THAT THE MANUAL BREAST PUMP CAUSED MASTITIS. THE DEVICE HAS BEEN TESTED AND BEEN FOUND PERFORMING ACCORDING TO SPECIFICATIONS. NO ANOMALIES HAVE BEEN DETECTED ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74064 PHILIPS AVENT MANUAL BREAST PUMP BREAST PUMP NOT-POWERED HGY PAYER INDUSTRIES HUNGARY SCF430/01 00075020109453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other