BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 5952704 · Received September 15, 2016

    Report

    Report Number
    3009974348-2016-00220
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    August 16, 2016
    Report Date
    August 17, 2016
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K073501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS TESTED PER AMEDA ENGINEERING PROTOCOL TO DETERMINE WHETHER THE ALLEGATION OF LEAKING FLUID COULD BE CONFIRMED. THE RETURNED PRODUCT WAS ASSESSED FOR INDICATIONS OF MALFUNCTION OR THERMAL EVENT. THE RETURNED PRODUCT WAS ASSESSED FOR FUNCTIONALITY AND MET FUNCTIONAL SPECIFICATIONS. THE BATTERY FLUID IS NOT OBSERVED IN THE BATTERY COMPARTMENT. . INTERNALLY, NO SIGNS OF FOREIGN SUBSTANCE, BURNING, MELTING OR CHARRING WERE OBSERVED. ADDITIONAL TESTING CONFIRMED THAT BATTERIES MAY LEAK WHEN THE AC ADAPTER IS USED IN CONJUNCTION WITH BATTERIES.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2016 TO REPORT PUMPING WITH THE PURELY YOURS BREAST PUMP WHILE IT WAS PLUGGED INTO AN ELECTRICAL OUTLET AT HOME WHEN AN EVENT OCCURRED. SHE HAD BATTERIES INSTALLED INSIDE THE BATTERY COMPARTMENT AT THE TIME.. SHE STATES THE SPEED AND SUCTION ON THE PUMP SUDDENLY INCREASED WITHOUT HER INTERVENTION. SHE STATES THE BATTERIES EXPLODED INSIDE THE BATTERY COMPARTMENT. CUSTOMER REPORTS THE PUMP WAS ON HER LAP WITH HER FINGERS BENEATH THE PUMP BASE WHEN THIS EVENT OCCURRED. HOT BATTERY ACID LEAKED FROM THE BATTERY COMPARTMENT BURNING HER LEFT POINTER FINGER. SHE RINSED HER FINGER WITH COLD WATER, BANDAGED HER FINGER YET DID NOT SEEK MEDICAL ATTENTION FOR THIS INJURY. CUSTOMER REPORTS HER FINGER HEALING WITHIN ONE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604700 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other