BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE HANDS-FREE BREASTPUMP

    MDR report key: 6090426 · Received November 9, 2016

    Report

    Report Number
    1419937-2016-00290
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K150499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT FREESTYLE BREAST PUMP. ON (B)(6) 2016, A MEDELA CLINICIAN FOLLOWED UP WITH THE CUSTOMER AT WHICH TIME SHE STATED THAT SHE WAS DIAGNOSED WITH MASTITIS BY HER OB/GYNE. SHE FINISHED TAKING HER ANTIBIOTIC, CLINDAMYCIN, 2 DAYS AGO, AND MASTITIS RESOLVED. THE PRODUCT WAS RECEIVED AND EVALUATED ON 11/09/2016. THE EVALUATION STATES THAT THE DEVICE PASSED ALL FUNCTIONAL TESTS, BUT DUE TO CUSTOMER DAMAGE, THE DISPLAY WAS DAMAGED. 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 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) 2016, THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT HER FREESTYLE BREAST PUMP WOULD NOT TURN ON. SHE ALSO REPORTED THAT SHE HAS MASTITIS AND IS ON CLINDAMYCIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741065 FREESTYLE HANDS-FREE BREASTPUMP PUMP, BREAST, POWERED HGX MEDELA AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other