BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 4301338 · Received November 5, 2014

    Report

    Report Number
    3009974348-2014-00054
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE PRODUCT HAS NOT BEEN RETURNED. A PRE-PAID (B)(4) RETURN LABEL WAS EMAILED TO THE CUSTOMER IN AN EFFORT TO OBTAIN THE PRODUCT FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILLED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE CUSTOMER CALLED AMEDA, INC. SHE STATED THAT SHE HEARD A POPPING AND FIZZING SOUND COMING FROM HER PURELY YOURS BREAST PUMP. SHE OPENED THE BATTERY COMPARTMENT DOOR AND OBSERVED A BUBBLING GRAY FLUID INSIDE. SHE DROPPED THE BATTERY COMPARTMENT DOOR ON THE FLOOR AND THE GRAY FLUID SPLASHED ON THE LOWER PART OF BOTH OF HER LEGS. SHE IMMEDIATELY WASHED THE AREAS WITH SOAP AND WATER. SHE STATED THAT NO INJURY OCCURRED AND SHE DID NOT SEEK MEDICAL ATTENTION EITHER IN PERSON OR BY PHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711599 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other