BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 3001592 · Received March 11, 2013

    Report

    Report Number
    1419937-2013-00140
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 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 DISCONTINUED BREAST FEEDING AND REQUESTED A REPLACEMENT TO TAKE BACK TO THE STORE AND STATED SHE COULD SHIP THE USED PRODUCT TO MEDELA FOR INVESTIGATION. IN F/U WITH THE CUSTOMER, SHE STATED THAT AFTER USING THE BREAST SHIELDS THAT SEVERE ITCHING BEGAN ON THE BREAST WHERE THE BREAST SHIELDS TOUCHED. THE CUSTOMER STATED THE ITCH TURNED INTO A RASH ALL OVER THE BREASTS, TO THE CHEST, AND DOWN HER ARMS TO HER WRISTS. THE CUSTOMER STATED SHE WENT TO SEE A DR AND WAS PRESCRIBED THE STEROID CREAM CLOBETASOL AND WAS INSTRUCTED TO DISCONTINUE USE. THE CUSTOMER STATED WITH THE STEROID CREAM CLEARED UP THE RASH WITHIN A WEEK AND THE CUSTOMER DID DISCONTINUE USE OF THE PRODUCT. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. THE INFO WAS FORWARDED TO A MEDELA CLINICIAN FOR REVIEW. THE CLINICIAN SPOKE WITH THE CUSTOMER ON (B)(4) 2012 AND CONFIRMED THAT THE CUSTOMER WAS TREATED WITH A STEROID CREAM WHICH PRECLUDED BREAST FEEDING OR PUMPING. THE CUSTOMER HAS SINCE STOPPED LACTATING AND IS FEEDING FORMULA TO HER BABY. THE CUSTOMER HAS FULLY RECOVERED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT AFTER USING THE BREAST PUMP SHE WAS BREAKING OUT IN A RASH AROUND THE NIPPLE, BREAST, CHEST, AND LEADING DOWN HER ARMS. CUSTOMER SPOKE WITH A PHYSICIAN AND WAS DIAGNOSED WITH CONTACT DERMATITIS. CUSTOMER WAS TOLD SHE WAS REACTING TO THE PLASTIC THE BREAST SHIELDS ARE MADE OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101304 PUMP IN STYLE BREAST PUMP HGX MEDELA, INC. 57063/8107084 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other