BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS ULTRA

    MDR report key: 5988704 · Received September 29, 2016

    Report

    Report Number
    3009974348-2016-00224
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    August 25, 2016
    Report Date
    September 6, 2016
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS ASSESSED FOR INDICATIONS OF MALFUNCTION OR THERMAL EVENT. THE RETURNED PRODUCT WAS ASSESSED FOR FUNCTIONALITY AND MET FUNCTIONAL SPECIFICATIONS. BATTERIES WERE NOT RETURNED WITH THE PUMP. ADDITIONAL TESTING CONFIRMED THAT BATTERIES MAY GET HOT AND LEAK WHEN THE UPPER MIDDLE BATTERY IS PLACED INCORRECTLY, WITH THE POSITIVE AND NEGATIVE END REVERSED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. TO REPORT SUSTAINING A BURN TO THE PAD OF HER LEFT RING FINGER WHEN A HOT BATTERY POPPED OUT OF THE BATTERY COMPARTMENT OF HER PURELY YOURS ULTRA BREAST PUMP AFTER SENSING THEY WERE BECOMING OVERHEATED. THIS OCCURRED WHILE MOM WAS PUMPING IN HER CAR ON (B)(6) 2016. CUSTOMER STATES SHE STRUGGLED WITH THE BATTERIES REMAINING SECURELY INSIDE THE BATTERY COMPARTMENT IN ORDER TO CLOSE THE COMPARTMENT DOOR. CUSTOMER REPORTS THE BURN AS MINOR, WASHED FINGER WITH CLEAN, COOL WATER AND DID NOT SEEK OUT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640113 PURELY YOURS ULTRA ELECTRIC BREAST PUMP HGX AMEDA, INC. 24501879

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR