BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDELA PUMP IN STYLE ADVANCED BREAST PUMP

    MDR report key: 1914350 · Received November 17, 2010

    Report

    Report Number
    1419937-2010-00045
    Event Type
    Other
    Date Received
    November 17, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 7, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPT TO CONTACT THE CUSTOMER WAS UNSUCCESSFUL, AS NO ACCURATE CONTACT INFO WAS PROVIDED. AS NO FURTHER INFO WAS PROVIDED AND THE ORIGINAL PRODUCT HAS NOT BEEN RETURNED FOR FURTHER EVAL, NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE CAN BE DETERMINED. SHOULD NEW INFO OR THE PRODUCT BE OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED AT THAT TIME. 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 REPORTED SHE WAS GIVEN THE BREAST PUMP IN (B)(6) 2010 AND HAD ONLY USED IT A FEW TIMES. SHE INDICATED IT WAS TOO PAINFUL FOR HER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other