BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY MANUAL BREAST PUMP

    MDR report key: 2191012 · Received July 29, 2011

    Report

    Report Number
    1419937-2011-00156
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K823840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE SENT THE CUSTOMER LARGER BREAST SHIELDS. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT WHEN SHE STARTED PUMPING, SHE FELT SORE SO SHE STOPPED USING THE PUMP. THE SORENESS GOT WORSE AND SHE TRIED TO GET HER DAUGHTER TO NURSE, BUT NOTHING WOULD COME OUT. SHE WAS DIAGNOSED WITH MASTITIS AND WAS PRESCRIBED TWO COURSES OF ANTIBIOTICS FOR TREATMENT. THE MASTITIS HAS BEEN RESOLVED. SHE DOESN'T NECESSARILY THINK IT WAS CAUSED BY THE PUMP, SHE FEELS LIKE IT WAS CAUSED BY INCORRECT BREAST SHIELD SIZING. SHE FEELS LIKE IT WAS BECAUSE SHE HADN'T EDUCATED HERSELF ON PUMPING AND THAT SHE DIDN'T GET FITTED FOR BREAST SHIELDS. "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." (B)(4). THE CUSTOMER WAS NOT ASKED TO RETURN THE PUMP, AS IT WAS INDICATED THAT THE CUSTOMER'S ISSUE WAS WITH BREAST SHIELD SIZING. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE MASTITIS. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES AND WILL INITIATE A CAPA AS NECESSARY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE IS NOT SURE IF SHE IS USING THE CORRECT BREAST SHIELD SIZE WITH HER BREAST PUMP AND IT IS CAUSING PAIN AND DISCOMFORT. SHE CURRENTLY HAS MASTITIS AND IT STARTED AFTER SHE BEGAN USING THE PUMP. SHE DIDN'T EXPRESS MILK THE FIRST DAY AND IT WORSENED. SHE IS CURRENTLY ON AN ANTIBIOTIC AND HAS AN APPOINTMENT SCHEDULED WITH HER DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONY MANUAL BREAST PUMP HGX MEDELA, INC. 67186

    Patients

    Seq Age Sex Outcome Treatment
    1 Other