BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREESTYLE BREAST PUMP

    MDR report key: 1943585 · Received December 9, 2010

    Report

    Report Number
    1419937-2010-00088
    Event Type
    Other
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE ISSUE WAS REPORTED AS A BLOG ON A WEBSITE, THE CUSTOMER CANNOT BE IDENTIFIED. THEREFORE, THE ISSUE CANNOT BE ADDRESSED WITH THE CUSTOMER, ADDITIONAL INFO CANNOT BE OBTAINED AND AN EVALUATION OF THE PRODUCT COULD NOT BE PERFORMED. AS A RESULT, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. WE WILL MONITOR AND TREND LIKE ISSUES AND INITIATE A CAPA AS APPLICABLE.

    Description of Event or Problem · 1

    AN UNIDENTIFIED CUSTOMER POSTED A BLOG THAT HER PUMP "OPERATES WITH A WEIRD VIBRATE AND PULL. EVEN ON ITS LOWER SETTINGS, IT LEFT A LOT OF PAINFUL BURNING. I STILL HAVE NUMBNESS 6 MONTHS LATER, SO I'M ASSUMING IT CREATED SCAR TISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BREAST PUMP NONE HGX MEDELA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other