BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE/BREASTSHIELDS

    MDR report key: 3950973 · Received July 14, 2014

    Report

    Report Number
    1419937-2014-00553
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HFS
    PMA / PMN Number
    K923577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT SHE HAS A RASH ON HER AREOLA THAT WAS INFECTED. HER DOCTOR PUT HER ON MYSTATIN OINTMENT, NEOSPRIN, HYDROCORTISONE CREAM 1%, DESONIDE OINTMENT 0.5%, CEPHALEXIN 50 MG 3X DAILY. 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. 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. THIS ISSUE IS CURRENTLY BEING INVESTIGATED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE BREASTSHIELDS SHE WAS USING WITH HER PUMP IN STYLE BREAST PUMP HAD CAUSED AN ALLERGIC REACTION THAT REQUIRED MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410169 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE/BREASTSHIELDS HFS MEDELA, INC. 8107175/87075/57063 NA

    Patients

    Seq Age Sex Outcome Treatment
    1