BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS AVENT SINGLE ELECTRIC BREAST PUMP ADVANCED

    MDR report key: 13077567 · Received December 23, 2021

    Report

    Report Number
    3010359222-2021-00005
    Event Type
    Injury
    Date Received
    December 23, 2021
    Report Date
    December 23, 2021
    Manufacturer
    PHILIPS CONSUMER LIFESTYLE B.V.
    Product Code
    HGX
    PMA / PMN Number
    K201381
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE LIMITED INFORMATION PROVIDED BY THE CUSTOMER, THE IMPOSSIBILITY TO CONDUCT A TECHNICAL INVESTIGATION OF THE DEVICE, WE ARE NOT ABLE TO COME TO A ROOT CAUSE. HOWEVER WE KNOW THAT PAIN AND BRUISES, SOMETIMES ACCOMPANIED BY BLEEDING OR BLISTERS ON THE NIPPLES ARE KNOWN SIDE EFFECTS OF NATURAL BREAST FEEDING AND ALSO KNOWN SIDE EFFECTS OF USING BREAST PUMPS. THE DEVICE HAS BEEN DESIGNED ACCORDING TO SAFETY STANDARDS AND IS SAFE TO USE WHEN USED ACCORDING TO THE DFU. PHILIPS CONTINUES TO MONITOR THIS TYPE OF EVENTS AS PART OF THE POST MARKET SURVEILLANCE PROCESS ACTIVITIES.

    Description of Event or Problem · 0

    A CUSTOMER CLAIMS THAT SHE GOT SORES ON BOTH SIDES OF HER BREAST FROM USING THE BREAST PUMP AND THAT SHE HAD TO GO TO THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977682 PHILIPS AVENT SINGLE ELECTRIC BREAST PUMP ADVANCED ELECTRIC BREAST PUMP HGX PHILIPS CONSUMER LIFESTYLE B.V. SCF391

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other