BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2850715 · Received November 23, 2012

    Report

    Report Number
    1419937-2012-00750
    Event Type
    Injury
    Date Received
    November 23, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, CONTACT WAS NOT MADE WITH THE CUSTOMER TO OBTAIN ADD'L INFO REGARDING THIS EVENT. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER, BUT WERE NOT SUCCESSFUL DUE TO AN INVALID EMAIL AND PHONE NUMBER. "MASTITIS IS USUALLY A BENIGN, SELF-LIMITING INFECTION, WITH FEW CONSEQUENCES FOR THE SUCKLING INFANT. THE RISK OF MASTITIS IN 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) IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMERS MASTITIS. SHOULD ADD'L INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW CHANGED OR CORRECTED INFO, A F/U REPORT WILL BE FILED. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NOT RECEIVING GOOD SUCTION AND DEVELOPING MASTITIS. THE BABY WOULD NOT LATCH ON AND SHE WAS UNABLE TO EMPTY HER BREAST. IT WAS ALSO NOW TAKING LONGER FOR HER TO EXPRESS WITH THE PUMP, SO SHE RENTED A HOSPITAL GRADE MODEL TO HELP RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE BREAST PUMP HGX MEDELA, INC. 57XXX

    Patients

    Seq Age Sex Outcome Treatment
    1