BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 6100606 · Received November 14, 2016

    Report

    Report Number
    3009974348-2016-00237
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 16, 2016
    Report Date
    October 17, 2016
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS CONTACTED BY EMAIL FIVE TIMES OVER A PERIOD OF THREE WEEKS REQUESTING SHE CONTACT AMEDA, INC. TO ASSIST HER IN RESOLVING THIS ISSUE. AMEDA DID NOT HAVE ANY OTHER MEANS OF CONTACTING THE CUSTOMER. THE CUSTOMER HAS NOT RESPONDED TO THE EMAILS TO SEEK A SOLUTION TO THIS PROBLEM. DUE TO A LACK OF RESPONSE BY THE CUSTOMER, NO PRODUCT WAS RETURNED TO AMEDA AND A REPLACEMENT PUMP BASE WAS NOT SENT TO THE CUSTOMER. THEREFORE NO VISUAL INSPECTION OR INVESTIGATION OF THE PUMP BASE COULD BE CONDUCTED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA PARENT CARE ONLINE ON (B)(6) 2016. SHE REPORTS HER AC ADAPTER STOPPED FUNCTIONING 1 MONTH PRIOR AND SINCE THAT TIME, SHE USES BATTERIES TO POWER ON THE PURELY YOURS BREAST PUMP SHE USES FOR PUMPING BREAST MILK. CUSTOMER REPORTS TWO BATTERIES STARTED TO LEAK DARK FLUID FROM THE BATTERY COMPARTMENT ON 2 SEPARATE OCCASIONS THE DAY BEFORE THE COMPLAINT WAS SENT TO AMEDA, INC. AT THIS TIME, IT IS UNKNOWN WHETHER CUSTOMER CAME IN CONTACT WITH THE BATTERY FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750336 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR