BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE HANDS FREE

    MDR report key: 4904976 · Received July 8, 2015

    Report

    Report Number
    1419937-2015-00213
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    June 23, 2015
    Report Date
    July 6, 2015
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDELA CUSTOMER SERVICE DETERMINED THAT THE CUSTOMER HAD BEEN SENT MULTIPLE PUMPS. IN ADDITION, THE AFFECTED PUMP IS NO LONGER UNDER WARRANTY. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S MASTITIS. REPORTED ISSUES OF MASTITIS ARE UNDER INVESTIGATION IN (B)(4). 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." RIORDAN AND 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) 2015, A CUSTOMER REPORTED TO MEDELA CUSTOMER SERVICE THAT HER FREESTYLE BREAST PUMP HAD LOW SUCTION. IN ADDITION, THE CUSTOMER REPORTED THAT SHE WAS DIAGNOSED WITH MASTITIS AND WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443074 FREESTYLE HANDS FREE HGX MEDELA, INC. 67060

    Patients

    Seq Age Sex Outcome Treatment
    1