BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

    MDR report key: 3093644 · Received May 1, 2013

    Report

    Report Number
    1419937-2013-00241
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT BREAST PUMP. IN BRIEF FOLLOW UP WITH THE CUSTOMER, SHE INDICATED SHE WAS STILL STRUGGLING WITH MASTITIS AND WAS TAKING ANTIBIOTICS PRESCRIBED BY A HEALTH CARE PROVIDER. THE FILE WAS REFERRED TO A CLINICIAN FOR REVIEW HOWEVER, THE REVIEW HAS NOT BEEN RECEIVED BACK. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S MASTITIS. REPORTED ISSUES OF MASTITIS ARE UNDER INVESTIGATION IN (B)(4). SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT HER BREAST PUMP HAD LOW SUCTION AND THAT SHE HAS HAD MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189348 PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK HGX MEDELA, INC. 57062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other