BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4846912 · Received June 12, 2015

    Report

    Report Number
    3009974348-2015-00116
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    September 16, 2013
    Report Date
    September 15, 2013
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT A REPLACEMENT PURELY YOURS MOTOR BASE ON 09/16/2013 AND WAS ASKED TO RETURN THE ORIGINAL MOTOR BASE TO AMEDA, INC. FOR EVALUATION. AN EXPEDITED FEDEX RETURN SHIPPING LABEL WAS PROVIDED FOR PRODUCT RETURN. PHONE CALLS WERE MADE TO CUSTOMER FOR RETURN SHIPMENT OF MOTOR BASE. THOUGH REQUESTED, THE REPORTED PRODUCT WAS NOT RETURNED TO AMEDA INC. FOR EVALUATION.

    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 09/16/2013 TO REPORT BLACK SUBSTANCE, ALLEGED TO BE OIL IS LEAKING FROM THE MOTOR OF THE PURELY YOURS BREAST PUMP DURING USE. THE RELEASE OF THE OIL DID NOT IMPACT THE FUNCTIONALITY OF THE PUMP AS THE CUSTOMER CONTINUED TO USE THE MOTOR UNIT UNTIL HER REPLACEMENT MOTOR ARRIVED. CUSTOMER DID NOT ALLEGE ANY INJURY OR BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383786 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1