BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 1785063 · Received February 15, 2010

    Report

    Report Number
    1419937-2007-00002
    Event Type
    Other
    Date Received
    February 15, 2010
    Date of Event
    December 10, 2007
    Report Date
    February 2, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010 - DURING FDA INSPECTION ON (B)(4) 2010; REVIEW OF COMPLAINT FILES, INSPECTOR DIAGNOSED WITH OUR INVESTIGATION'S "NON-REPORTABLE" DISPOSITION OF EVENT (B)(4). SHE BELIEVED THAT NIPPLE DAMAGE IS A REPORTABLE EVENT AND A MDR SHOULD HAVE BEEN FILED WITHIN 30 DAYS OF THE REPORTED EVENT. WE ARE NOW SUBMITTING THIS MDR IN COMPLIANCE TO OBSERVATION #(B)(4).

    Description of Event or Problem · 1

    NEW MOTHER BEGAN USING THE BREAST PUMP WITH NO PROFESSIONAL CONSULTATION (LACTATION CONSULTANT). AFTER HER INITIAL ATTEMPTS WITH 27 MM BREAST SHIELDS CAUSED PAIN AT THE BREAST, SHE PURCHASED LARGER SIZE BREAST SHIELDS AT RETAIL, AND ATTEMPTED TO USE THEM. BASED ON HER COMMENTS WHEN SHE CALLED INTO MEDELA TO COMPLAIN OF TRAUMA, THE NEW BREAST SHIELDS WERE TOO LARGE AND ALLOWED A SIGNIFICANT PORTION OF HER AREOLA TO BE PULLED INTO THE PUMPING CHAMBER. RATHER THAN ALLEVIATING THE PAIN, THIS AGGRAVATED IT. DURING THIS PROCESS, THE MOTHER NOTED DAMAGE TO THE AREOLA, ABRASION AND TEARING. THIS IS WHEN SHE CALLED IN TO COMPLAIN AND WAS REFERRED TO OUR LACTATION CONSULTANT FOR ASSISTANCE. THE MOTHER DID NOT FOLLOW UP FOR A CONSULTATION OR RETURN OUR LC'S SUBSEQUENT CALLS. THE MOTHER STATED SHE STOPPED PUMPING AND NURSING, AND HER NIPPLES HEALED. IT IS NOT CERTAIN WHAT ISSUE THERE MAY HAVE BEEN WITH THE ORIGINAL BREAST SHIELDS, BASED ON THE INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED BREAST PUMP, POWERED HGX MEDELA, INC. METRO BAG 57030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other