BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS AVENT NATURAL MANUAL BREAST PUMP

    MDR report key: 12189012 · Received July 19, 2021

    Report

    Report Number
    3010359222-2021-00003
    Event Type
    Injury
    Date Received
    July 19, 2021
    Report Date
    August 25, 2021
    Manufacturer
    PHILIPS CONSUMER LIFESTYLE B.V.
    Product Code
    HGY
    PMA / PMN Number
    K101538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER REPORTED THAT THE DIAPHRAM OF THE MANUAL BREAST PUMP WAS CRACKED. SHE CONTINUED USING THE DEVICE FOR TWO WEEKS. SHE BEGAN TO FEEL UNWELL AND CONTACTED HER DOCTOR WHO DIAGNOSED HER WITH MASTITIS. THE PRODUCT DIRECTIONS FOR USE INCLUDES A WARNING STATING TO DISCONTINUE USE IF THE BREAST PUMP GETS BADLY SCRATCHED OR IF IT CRACKS, HOWEVER THE USER CONTINUED TO USE THE PRODUCT. FOLLOW-UP 08/25/2021: THE CONSUMER WAS NOT ABLE TO RETURN THE DEVICE FOR INVESTIGATION, THEREFORE NO PRODUCT INVESTIGATION WAS ABLE TO BE PERFORMED.

    Description of Event or Problem · 0

    THE CONSUMER COMPLAINS THAT HE HAS MASTITIS IN HIS BREAST DUE TO A CRACK IN THE PILLOW.

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THAT THE DIAPHRAM OF THE MANUAL BREAST PUMP WAS CRACKED. SHE CONTINUED USING THE DEVICE FOR TWO WEEKS. SHE BEGAN TO FEEL UNWELL AND CONTACTED HER DOCTOR WHO DIAGNOSED HER WITH MASTITIS. THE PRODUCT DIRECTIONS FOR USE INCLUDES A WARNING STATING TO DISCONTINUE USE IF THE BREAST PUMP GETS BADLY SCRATCHED OR IF IT CRACKS, HOWEVER THE USER CONTINUED TO USE THE PRODUCT.

    Description of Event or Problem · 1

    THE CONSUMER COMPLAINS THAT HE HAS MASTITIS IN HIS BREAST DUE TO A CRACK IN THE PILLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089967 PHILIPS AVENT NATURAL MANUAL BREAST PUMP NONPOWERED BREAST PUMP HGY PHILIPS CONSUMER LIFESTYLE B.V. SCF330/13

    Patients

    Seq Age Sex Outcome Treatment
    1 Other