BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE

    MDR report key: 1914448 · Received November 20, 2010

    Report

    Report Number
    1419937-2010-00082
    Event Type
    Other
    Date Received
    November 20, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO THIS CUSTOMER, A REPLACEMENT PUMP WAS SENT ON (B)(4) 2010. THE CUSTOMER INDICATED THAT THE REPLACEMENT PUMP IS NOT CAUSING ANY ISSUES. THE CUSTOMER STATED THAT SHE RETURNED THE PRODUCT INVOLVED IN THE COMPLAINT; HOWEVER, THERE IS NO INDICATION THAT THE PRODUCT HAS BEEN REC'D. AN EVAL OF THE PRODUCT COULD NOT BE PERFORMED. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. 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

    CUSTOMER STATED THAT IT IS VERY PAINFUL WHEN PUMPING AND IT FELT LIKE IT WAS GOING TO PULL HER NIPPLE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE PUMP, BREAST, POWERED HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other