BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 5065521 · Received September 9, 2015

    Report

    Report Number
    3009974348-2015-00166
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 11, 2015
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SHIPPED A REPLACEMENT PURELY YOURS BREAST PUMP ON (B)(4) 2015. THE CUSTOMER WAS PHONED TWICE AND EMAILED TWICE REQUESTING RETURN OF THE PURELY YOURS BREAST PUMP TO AMEDA, INC. FOR INVESTIGATION. AS OF THIS DATE, THE PUMP HAS NOT BEEN RETURNED TO AMEDA, INC. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PUMP IS RETURNED TO AMEDA.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2015 TO REPORT HEARING A HISSING SOUND COMING FROM THE BATTERY COMPARTMENT AS SHE PUMPED WITH THE PURELY YOURS BREAST PUMP ON (B)(6) 2015. CUSTOMER PRIMARILY USES BATTERIES, NOT THE AC ADAPTER TO POWER HER BREAST PUMP. SHORTLY AFTER HEARING THIS HISSING SOUND, THE BATTERIES INSIDE THE BATTERY COMPARTMENT EXPLODED. SHE OPENED THE COMPARTMENT DOOR AND CLOSED IT IMMEDIATELY, AVOIDING CONTACT WITH THE DARK GRAY FLUID SHE NOTED INSIDE THE COMPARTMENT. CUSTOMER DENIES INJURY, BURN OR PROPERTY DAMAGE IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597129 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR