BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELVIE DOUBLE BREAST PUMP

    MDR report key: 13446276 · Received February 2, 2022

    Report

    Report Number
    MW5107192
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    January 29, 2022
    Report Date
    February 1, 2022
    Manufacturer
    CHIARO TECHNOLOGY LIMITED
    Product Code
    HGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT'S THE ELVIE DOUBLE ELECTRIC BREAST PUMP. IT GOT HOT TO THE POINT IT BURNED ME AND LEFT MARKS/BRUISES ON MY BREASTS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550982 ELVIE DOUBLE BREAST PUMP PUMP, BREAST, POWERED HGX CHIARO TECHNOLOGY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Hospitalization| R