BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3022798 · Received March 22, 2013

    Report

    Report Number
    1419937-2013-00167
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE SENT THE CUSTOMER REPLACEMENT PARTS/ACCESSORIES. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT HER BABY HAS BEEN TREATED FOR THRUSH AND SHE HERSELF HAS HAD RECURRENT YEAST INFECTIONS WHICH BEGAN IN (B)(6) OF 2012. HER CERTIFIED NURSE MIDWIFE DIAGNOSED THE YEAST INFECTIONS AND PRESCRIBED DIFLUCAN, AN ALL-PURPOSE NIPPLE OINTMENT, NYSTATIN, GENTIAN VIOLET AND CLOTRIMAZOLE AS TREATMENTS. ALL ARE OVER-THE-COUNTER MEDICATIONS WITH THE EXCEPTION OF THE NYSTATIN. AT THE TIME OF CONTACT, THE CUSTOMER INDICATED THAT SHE HAS "TENTATIVELY HEALED." CLINICAL STAFF ATTEMPTED TO CONTACT THE CUSTOMER, BUT WERE UNSUCCESSFUL. INSTEAD, AN E-MAIL WAS SENT WITH EVIDENCE-BASED INFORMATION REGARDING THRUSH IN NURSING BABIES AND MOTHERS USING BREAST PUMPS. ADDITIONALLY, PROPER CARE FOR BOTH MOTHER AND BABY AND METICULOUS PUMP HYGIENE ADVICE WAS PROVIDED. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED, OR CONTRIBUTED TO, THE YEAST INFECTIONS. COMPLAINTS WILL BE MONITORED FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT HER BABY HAS THRUSH AND HER LACTATION CONSULTANT INDICATED THAT IT IS "PROBABLY FROM THE [BREAST] PUMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119679 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other