BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCE METRO BAG

    MDR report key: 2050757 · Received March 31, 2011

    Report

    Report Number
    1419937-2011-00052
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER AS WELL AS A LABEL FOR THE RETURN OF THE ORIGINAL PUMP. THE ORIGINAL PUMP WAS NOT RETURNED FOR EVALUATION. IT IS NOT DEFINITIVELY CLEAR WHETHER OR NOT THE PUMP CONTRIBUTED TO THE CUSTOMER'S MASTITIS. AS THERE IS NO INFORMATION TO CLEARLY RULE OUT THE PUMP CONTRIBUTING TO THE MASTITIS, A MEDWATCH IS BEING SUBMITTED. AS PART OF COMPLAINT REMEDIATION ACTIVITIES, HISTORICAL COMPLAINT RECORDS ARE BEING REVIEWED FOR POSSIBLE ADVERSE EVENTS. MEDELA IS COMMITTED TO CREATING AN EFFECTIVE COMPLAINT HANDLING PROCESS TO ASSURE COMPLAINTS ARE PROCESSED IN A TIMELY MANNER AND EVALUATED FOR PART 803 REPORTING.

    Description of Event or Problem · 1

    THE CUSTOMER STATED SHE PURCHASED HER PUMP ABOUT 30 DAYS PRIOR. CUSTOMER REPORTED SHE GOT MASTITIS AND DOES NOT WANT OT USE HER BREAST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCE METRO BAG HGX MEDELA, INC. 57036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other