BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP STARTER

    MDR report key: 4448175 · Received January 20, 2015

    Report

    Report Number
    1419937-2015-00019
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    January 15, 2015
    Report Date
    January 16, 2015
    Manufacturer
    MEDELA INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW PUMP WAS SENT TO THE CUSTOMER. 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 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. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT RE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE ON (B)(6) 2014 THAT SHE WAS EXPERIENCING HIGH SUCTION WITH HER PUMP IN STYLE ADVANCED BREAST PUMP WHICH CAUSED HER PAIN AND A TORN NIPPLE. DURING PRODUCT RETURN FOLLOW UP WITH THE CUSTOMER ON (B)(6) 2015, THE CUSTOMER REPORTED THAT SHE HAD MASTITIS. HER OB PRESCRIBED DICLOXACILLIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45685 PUMP IN STYLE ADVANCED BREASTPUMP STARTER HGX MEDELA INC. 57081

    Patients

    Seq Age Sex Outcome Treatment
    1