BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY PREEMIE+ BREAST PUMP

    MDR report key: 5011416 · Received August 18, 2015

    Report

    Report Number
    1419937-2015-00244
    Event Type
    Injury
    Date Received
    August 18, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 18, 2015
    Manufacturer
    MEDELA INC.
    Product Code
    HGX
    PMA / PMN Number
    K020518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT REPLACEMENT KIT COMPONENTS. 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. 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. 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. IN FOLLOW-UP WITH THE CUSTOMER, SHE STATES SHE WENT TO HER OB/GYN, SHE HAD A FEVER AND RED STREAK DOWN HER BREAST. DR CONFIRMED SHE HAD MASTITIS AND PRESCRIBED DICLOXACILLIN FOR 10 DAYS. MASTITIS SEEMED TO HAVE GONE AWAY, BUT THEN SEEMED TO COME BACK. WAS PRESCRIBED ANOTHER 10 DAYS OF DICLOXACILLIN AND SHE NOW HAS NO SIGNS OF MASTITIS.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED TO CUSTOMER SERVICE ON (B)(6) 2015 THAT SHE NOTICED A WHITE RESIDUE ON HER MEMBRANES AND MEMBRANE CAPS FOR HER SYMPHONY PUMP. MOM FOLLOWED UP WITH COMPLAINT HANDLER ON (B)(6) 2015 AND REPORTED THAT SHE HAD DEVELOPED MASTITIS TWICE, FOR WHICH SHE WAS PRESCRIBED TWO ROUNDS OF DICLOXACILLIN BY HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545837 SYMPHONY PREEMIE+ BREAST PUMP HGX HGX MEDELA INC. 0240110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other