BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4943570 · Received July 21, 2015

    Report

    Report Number
    3009974348-2015-00154
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    January 3, 2014
    Report Date
    January 3, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT A REPLACEMENT AC ADAPTER AND PURELY YOURS BREAST PUMP BASE. SHE WAS INSTRUCTED TO RETURN THE AC ADAPTER AND BREAST PUMP BACK TO AMEDA, INC. FOR TESTING, USING THE PREPAID FEDEX LABEL SENT TO HER. SEVERAL ATTEMPTS WERE MADE TO CONTACT CUSTOMER TO ENCOURAGE PRODUCT RETURN. AS OF THIS DATE, THE AC ADAPTER AND PURELY YOURS BREAST PUMP HAVE NOT BEEN RETURNED TO AMEDA, INC. FOR TESTING.

    Description of Event or Problem · 1

    AS PART OF AMEDA, INC.'S QUALITY MANAGEMENT SYSTEM ACTIVITIES, A REVIEW OF HISTORICAL COMPLAINTS WAS CONDUCTED. IT WAS DETERMINED THAT THIS COMPLAINT SHOULD HAVE BEEN REPORTED TO FDA. CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2014 TO REPORT THE AC ADAPTER SHE USES TO POWER ON THE PURELY YOURS BREAST PUMP HAS GIVEN HER A SHOCK WHEN PLUGGING IT IN. SHE REPORTS THE AC ADAPTER CASING HAD FALLEN OFF. CUSTOMER STATES SHE HAD WET HANDS WHEN PLUGGING IN THE AC ADAPTER. CUSTOMER DENIED ANY INJURY, BURN OR PROPERTY DAMAGE AND DID NOT SEEK ANY MEDICAL ADVICE/TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473182 PURELY YOURS ELECTRIC BREAST PUMP, 884.5160 HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1