BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS ULTRA

    MDR report key: 7049509 · Received November 21, 2017

    Report

    Report Number
    3009974348-2017-00298
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    October 24, 2017
    Report Date
    October 26, 2017
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    UDI-DI
    00810725021484
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS PHONED AND EMAILED A TOTAL OF 4 TIMES REQUESTING RETURN OF THE BREAST PUMP BASE TO AMEDA, INC. TO INVESTIGATE THE CAUSE OF BATTERY LEAKAGE. AS OF THIS DATE, THE PUMP BASE HAS NOT BEEN RETURNED TO AMEDA THEREFORE NO VISUAL EXAMINATION OR EVALUATION COULD BE CONDUCTED. IF THE PUMP BASE IS RETURNED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE FILED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON 10/26/2017 TO REPORT HER PURELY YOURS ULTRA BREAST PUMP LEAKED DARK FLUID FROM THE BATTERY COMPARTMENT WHILE PUMPING IN HER CAR ON (B)(6) 2017. SHE USES BATTERY POWER TO OPERATE HER BREAST PUMP WHEN DRIVING. CUSTOMER STATES THE BATTERIES WERE NEW OUT OF THE PACKAGE. SHE HAD THE PUMP BASE POSITIONED ON HER LAP WHILE PUMPING. SHE FELT A BURNING SENSATION ON HER LEFT THIGH THEN NOTED BLACK FLUID LEAKING FROM THE BATTERY COMPARTMENT ONTO HER LEG. CUSTOMER ESTIMATES THE SIZE OF THE BURN TO BE A HALF DOLLAR IN THE CENTER OF HER LEFT THIGH. HER LEGGINGS WERE NOT BURNED HOWEVER HER SKIN BECAME RED, BLISTERED AND LATER SCABBED WITHIN 1 DAY. SHE INQUIRED ABOUT BURN CARE FROM HER CARDIOLOGIST SHE HAD AN APPOINTMENT WITH THE NEXT DAY. HE DID NOT RECOMMEND ANY SPECIAL TREATMENT OF BURN SITE BUT TO KEEP AREA CLEAN. BURN AREA HEALED WITHIN 2 DAYS AFTER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827172 PURELY YOURS ULTRA ELECTRIC BREAST PUMP HGX AMEDA, INC. 24501879 00810725021484

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other