BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE HANDS-FREE BREASTPUMP

    MDR report key: 7068517 · Received November 29, 2017

    Report

    Report Number
    1419937-2017-00334
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    November 1, 2017
    Report Date
    January 2, 2018
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K150499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE CONNECTORS AND BARRIERS FOR EVALUATION, WHICH WAS PERFORMED ON 11/30/2017 AND IT WAS DETERMINED THAT THE ROOT CAUSE OF THE CUSTOMER'S LOW SUCTION ISSUE CAN BE ATTRIBUTED TO A MOLDING DEFICIENCY ON THE CONNECTORS SEALING SURFACE. CURRENTLY THERE IS AN OPEN INVESTIGATION (CAPA (B)(4)), WHICH IDENTIFIED MOLDING ENHANCEMENTS TO CORRECT THIS DEFICIENCY, WHICH WERE PUT IN PLACE IN JULY OF 2017.

    Additional Manufacturer Narrative · 1

    REPLACEMENT PARTS WERE SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT THE REPLACEMENT PARTS WERE WORKING WITHOUT ISSUE AND THE MASTITIS WAS RESOLVED. BASED ON THE RESULTS OF (B)(4), IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S MASTITIS. "MASTITIS IS USUALLY A BENIGN, SELF-LIMITING INFECTION WITH FEW CONSEQUENCES FOR THE SUCKLING INFANT. THE RISK OF MASTITIS IS HIGHER AMONG WOMEN WHO HAVE BREASTFED PREVIOUSLY, ESPECIALLY THOSE WITH A HISTORY OR MASTITIS." RIORDAN & WAMBACH, 4TH ED. P. 294: BREASTFEEDING AND HUMAN LACTATION. MASTITIS REQUIRES PROMPT MEDICAL ATTENTION FOR THE MOTHER FOR PAIN RELIEF AND PRESCRIPTION ANTIBIOTICS TO AVOID PROGRESSION TO OVERWHELMING SEPSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE BOUGHT THREE SETS OF SPARE PARTS FOR HER FREESTYLE BREAST PUMP AND THEY DID NOT WORK. SHE ALLEGED THAT SHE HAD MASTITIS FOR WHICH SHE WAS PRESCRIBED AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848145 FREESTYLE HANDS-FREE BREASTPUMP PUMP, BREAST, POWERED HGX MEDELA AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other