BEUDAMED
    FDA Adverse Event Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP SHOULDER BAG

    MDR report key: 3842655 · Received May 19, 2014

    Report

    Report Number
    1419937-2014-00418
    Date Received
    May 19, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACE TRANSFORMER WAS SENT TO THE CUSTOMER. THE CAUSE OF THE BREACH IN THE 9207041 TRANSFORMER HAS NOT BEEN DETERMINED AT THIS TIME. IT IS CURRENTLY BEING INVESTIGATED UNDER (B)(4). THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD ADD'L INFO OR THE ORIGINAL PRODUCT BE REC'D, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT HER TRANSFORMER HOUSING HAS CRACKED, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295058 PUMP IN STYLE ADVANCED BREAST PUMP SHOULDER BAG HGX MEDELA, INC. 57026/9207041 1242

    Patients

    Seq Age Sex Outcome Treatment
    1