BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HGX

    MDR report key: 3518895 · Received December 6, 2013

    Report

    Report Number
    1419937-2013-00705
    Event Type
    Injury
    Date Received
    December 6, 2013
    Date of Event
    November 5, 2013
    Report Date
    November 19, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL AND ARE ONGOING. THE ORIGINAL PRODUCT WILL NOT BE RETURNED. SHOULD ADD'L INFO BECOME AVAILABLE RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILED AT THAT TIME. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S MASTITIS. REPORTED ISSUES OF MASTITIS ARE UNDER INVESTIGATION IN (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE BELIEVED SHE WA EXPERIENCING LOW MILK EXPRESSION WITH HER PUMP IN STYLE BREAST PUMP. SHE ALSO REPORTED THAT SHE CURRENTLY HAS CLOGGED DUCTS AND HAS HAD MASTITIS, WHICH SHE WAS TREATED FOR. THE CUSTOMER STATED THAT SHE IS GOING TO RENT A SYMPHONY PUMP. AT THE TIME OF THE CALL, THE CUSTOMER WAS NOT ABLE TO GO THROUGH TROUBLESHOOTING, THEREFORE THE PUMP RETURN WAS NOT REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633975 HGX BP ADVANCED PERSONAL DOUBLE HGX MEDELA, INC. 57065

    Patients

    Seq Age Sex Outcome Treatment
    1