BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE HANDS FREE

    MDR report key: 2841925 · Received November 14, 2012

    Report

    Report Number
    1419937-2012-00723
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. A MEDELA CLINICIAN SPOKE WITH THE CUSTOMER ON (B)(4) 2012, SHE INDICATED THAT SHE WAS EXPERIENCING LOW SUCTION WITH THE PUMP. THE CUSTOMER THEN DEVELOPED MASTITIS AND WAS IN THE HOSPITAL RECEIVING TREATMENT WITH ANTIBIOTICS. THE CUSTOMER CONFIRMED THAT THE NEW PUMP SHE WAS SENT IS WORKING WELL AND THAT SHE HAS FULLY RECOVERED FROM MASTITIS. THE ORIGINAL PRODUCT WAS RECEIVED BY MEDELA ON (B)(4) 2012, HOWEVER AN EVALUATION OF THE UNIT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED. "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)).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD MASTITIS AND THAT THEIR FREESTYLE DEVICE HAD LOW SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE HANDS FREE HGX MEDELA, INC. 67060

    Patients

    Seq Age Sex Outcome Treatment
    1