BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 6223312 · Received January 4, 2017

    Report

    Report Number
    3009974348-2017-00241
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    December 7, 2016
    Report Date
    December 7, 2016
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, IT WAS FOUND THAT BATTERIES WERE INSTALLED BACKWARDS IN THE BATTERY COMPARTMENT. ADDITIONAL TESTING CONFIRMED THAT BATTERIES MAY LEAK WHEN THE BATTERIES ARE PLACED INCORRECTLY, WITH THE POSITIVE AND NEGATIVE END REVERSED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2016 TO REPORT BATTERY FLUID LEAKING FROM THE BASE OF THE PURELY YOURS BREAST PUMP SHE USED THAT MORNING ON BATTERY POWER. SHE STATES THAT THE PUMP BEGAN SOUNDING WEAK AND SLOWING UP. SHE STOPPED PUMPING, OPENED THE BATTERY COMPARTMENT AND FOUND LEAKING BLACK FLUID COMING FROM THE BATTERIES IN BASE. SOME FLUID LEAKED ONTO HER RIGHT LEG, STAINED HER PANTS AND BURNED HER THIGH. CUSTOMER WASHED HER RIGHT THIGH WITH COOL WATER AND DID NOT SEEK MEDICAL ATTENTION. SHE DESCRIBED THE BURN AS A RED SPOT THE SIZE OF A HALF DOLLAR AND SKIN INTACT WITHOUT BLISTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6900 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other