BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4136197 · Received September 9, 2014

    Report

    Report Number
    3009974348-2014-00024
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 19, 2014
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, A REPLACEMENT PUMP WAS SHIPPED TO THE CUSTOMER AS WELL AS A REQUEST AND PRE-PAID LABEL TO RETURN THE ORIGINAL PUMP TO AMEDA. ON (B)(4) 2014, A CERTIFIED LETTER WAS SENT TO THE CUSTOMER REQUESTING THAT THE PUMP BE RETURNED FOR EVALUATION. THE PRODUCT HAS NOT BEEN RETURNED TO AMEDA, INC. AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED AMEDA VIA PHONE CALL ON 08/19/2014. SHE STATED THAT ONE WEEK AGO (ON (B)(6) 2014) AFTER A PUMPING SESSION, SHE TURNED THE PURELY YOURS BREAST PUMP OFF AND HER (B)(6) YEAR OLD SON IMMEDIATELY "TRIED TO PICK UP THE PUMP AND BURNT HIS FINGERS OF HIS RIGHT HAND WERE BURNED. THE CUSTOMER STATED SHE APPLIED COLD WATER TO HER SON'S FINGER TIPS. WHEN ASKED IF SHE SOUGHT MEDICAL ATTENTION, SHE REPLIED, "NO, HE SEEMS FINE NOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555927 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR