BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BREAST PUMP

    MDR report key: 2844368 · Received November 16, 2012

    Report

    Report Number
    1419937-2012-00732
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    MEDELA, AG
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDELA CLINICIAN SPOKE TO THE CUSTOMER ON (B)(4) 2012, THE CUSTOMER HAD REPORTED A PROBLEM WHEN USING A FREESTYLE BREAST PUMP. THE CUSTOMER DID NOT EMPTY HER BREASTS WELL AND HAD RECURRENT PROBLEMS WITH CLOGGED DUCTS. THIS RESULTED IN A BOUT OF MASTITIS WHICH REQUIRED MEDICAL ATTENTION AND A COURSE OF ANTIBIOTICS. THE CUSTOMER REPORTS THAT SHE HAS FINISHED THE ANTIBIOTICS AND FEELS SHE HAS RECOVERED COMPLETELY FROM MASTITIS. SHE HAS RECEIVED THE REPLACEMENT PARTS AND FINDS THEY MAKE 'A WORLD OF DIFFERENCE' IN THE PUMP'S PERFORMANCE. SHE FEELS THAT THE PARTS SHE REPLACED WERE OLD AND DID NOT WORK EFFICIENTLY IN THE PUMP, SO THE NEW PARTS HAVE MADE A POSITIVE DIFFERENCE. "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 OF MASTITIS." ["BREASTFEEDING AND HUMAN LACTATION" (RIORDAN AND WAMBACH, 4TH EDITION, PAGE 294)]. CAPA (B)(4) WAS OPENED TO INVESTIGATE COMPLAINTS RELATED TO MASTITIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE IS UNABLE TO EXPRESS ALL OF HER MILK USING THE FREESTYLE PUMP. THE CUSTOMER ALSO REPORTED THAT SHE IS GETTING CLOGGED DUCTS ON A REGULAR BASIS AND WAS TREATED FOR MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BREAST PUMP HGX MEDELA, AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1