BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

    MDR report key: 8032148 · Received November 2, 2018

    Report

    Report Number
    1419937-2018-00244
    Event Type
    Injury
    Date Received
    November 2, 2018
    Date of Event
    September 19, 2018
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE RESPONDED TO THE CUSTOMER VIA RETURN EMAIL THAT IT WOULD BE BEST TO TROUBLESHOOT THE LOW SUCTION ISSUE WITH HER PUMP VIA PHONE OR CHAT. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2018, THE CUSTOMER INDICATED THAT SHE DEVELOPED CLOGGED DUCTS AND NIPPLE BRUISING, FOR WHICH SHE WAS PRESCRIBED AN ALL-PURPOSE NIPPLE CREAM. THE CUSTOMER INDICATED THAT SHE BELIEVES THAT THE LOW SUCTION SHE WAS EXPERIENCING WITH THE PUMP IN STYLE BREAST PUMP CAUSED THE ISSUES SHE HAD WHEN SHE FIRST PURCHASED THE PUMP, BUT ONLY BECAME AWARE OF IT WHEN SHE RECENTLY BROUGHT THE PUMP TO HER LACTATION CONSULTANT. SHE HAS SINCE PURCHASED A COMPETITOR PUMP AND IS NO LONGER HAVING AN ISSUES WITH PAIN OR LOW OUTPUT. THE CUSTOMER WAS ADVISED BY THE COMPLAINT HANDLER TO CONTACT CUSTOMER SERVICE TO COME TO RESOLUTION OF HER ISSUE. THE CUSTOMER HAS NOT CONTACTED CUSTOMER SERVICE AS OF THE DATE OF THIS REPORT. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATION WAS PRESCRIBED).

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER REPORTED TO MEDELA LLC VIA EMAIL THAT SHE PURCHASED A PUMP IN STYLE BREAST PUMP WHEN HER SON WAS BORN IN (B)(6) AND, AT THE TIME, SHE HAD ISSUES WITH PAIN AND LOW OUTPUT (A SEARCH OF COMPLAINTS INDICATES THAT THE CUSTOMER DID NOT REPORT THE ISSUE BACK IN 2016). THE CUSTOMER ALLEGED THAT A FEW WEEKS AGO SHE WENT TO USE THE PUMP AGAIN WITH THE BIRTH OF HER DAUGHTER, AND WAS AGAIN EXPERIENCING PAIN AND LOW OUTPUT. SHE INDICATED THAT SHE TOOK THE PUMP TO A LACTATION CONSULTANT WHO USED A MEDELA SUCTION GAUGE TO DETERMINE THAT THE PUMP WAS NOT OPERATING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875364 PUMP IN STYLE ADVANCED - ON-THE-GO TOTE PUMP, BREAST, POWERED HGX MEDELA LLC 57063 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other