BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE HANDS-FREE BREASTPUMP

    MDR report key: 7148995 · Received December 27, 2017

    Report

    Report Number
    1419937-2017-00363
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    December 8, 2017
    Report Date
    December 27, 2017
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K150499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACEMENT SPARE PARTS WERE SENT TO THE CUSTOMER. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 12/27/2017, THE CUSTOMER CONFIRMED THAT SHE WAS DIAGNOSED AND TREATED FOR A YEAST INFECTION. SHE INDICATED THAT THE REPLACEMENT PARTS WERE WORKING WITHOUT ISSUE AND THAT THE YEAST INFECTION HAS SINCE RESOLVED. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S THRUSH. REPORTED ISSUES OF THRUSH WERE INVESTIGATED UNDER (B)(4) AND THE ROOT CAUSES WERE IDENTIFIED AS: LACK OF EDUCATION/TRAINING TO MOTHERS ON BREAST FEEDING AND BREAST MILK PUMPING; INSUFFICIENT GUIDANCE ON BREAST SHIELD SIZING TO PREVENT NIPPLE TRAUMA; INSUFFICIENT PERSONAL HYGIENE PRACTICES PRIOR TO BREAST MILK PUMPING OR BREAST FEEDING; AND NO ACCESS TO OR NOT FOLLOWING THE MANUFACTURES' INSTRUCTIONS FOR THE CLEANING AND SANITATION OF THE BREAST MILK PUMPING COMPONENTS. NO CORRECTIVE ACTIONS RESULTED AS IT WAS DETERMINED THAT DETAILED INSTRUCTIONS ARE AVAILABLE AND ADEQUATE IN BOTH PRINTED AND ON-LINE FORMATS FOR CLEANING BREAST MILK PUMPING EQUIPMENT, PERSONAL HYGIENE, PROPER BREAST SHIELD SIZING TO PREVENT NIPPLE SORENESS/TRAUMA, WHICH CAN LEAD TO SKIN BREACHES, ALLOWING FOR THE POTENTIAL INTRODUCTION OF YEAST.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE BACK COVER ON THE SPARE PARTS FOR HER FREESTYLE BREAST PUMP ARE CRACKED. SHE INDICATED THAT BOTH SHE AND HER BABY HAVE THRUSH, FOR WHICH SHE RECEIVED PRESCRIPTION MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927414 FREESTYLE HANDS-FREE BREASTPUMP PUMP, BREAST, POWERED HGX MEDELA AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other