BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCE METRO BAG

    MDR report key: 2050734 · Received March 31, 2011

    Report

    Report Number
    1419937-2011-00048
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A CLINICIAN SPOKE WITH THE CUSTOMER ON (B)(4) 2011. THE CUSTOMER STATED SHE BEGAN SINGLE PUMPING WITH A SWING BREASTPUMP. SHE REPLACED THE PUMP IN STYLE ADVANCED (PNSA) METRO. CUSTOMER STATED SHE NEVER FELT LIKE THE PNSA EMPTIED HER BREASTS WHILE DOUBLE PUMPING. SHE WENT TO SEE HER MD AND WAS TREATED FOR MASTITIS WITH ANTIBIOTICS. THE MASTITIS HAS RESOLVED. IT IS NOT DEFINITIVELY CLEAR WHETHER OR NOT THE PUMP CONTRIBUTED TO THE CUSTOMER'S MASTITIS. IT IS POSSIBLE THE CUSTOMER WAS CONDITIONED TO THE SWING SINGLE BREAST PUMP, AND THUS NEVER PUMPED WELL WITH THE DOUBLE PUMP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS HER PUMP IS NOT WORKING, AND SHE HAS MASTITIS AND IS IN A LOT OF PAIN. PER THE CUSTOMER, THE PUMP IS ONLY EXPRESSING 1OZ. OF MILK; SHE USED TO EXPRESS 10OZ.

    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