BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP STARTER

    MDR report key: 5114067 · Received September 30, 2015

    Report

    Report Number
    1419937-2015-00285
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 29, 2015
    Manufacturer
    MEDELA INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH A MEDELA CLINICIAN ON 09/02/2015, THE CUSTOMER REPORTED THAT SHE HAD BEEN PRESCRIBED ANTIBIOTICS BY HER PHYSICIAN TO TREAT MASTITIS. THE CUSTOMER ALSO REPORTED THAT SHE HAD RECOVERED FULLY FROM THE MASTITIS. AS OF THE DATE OF THIS REPORT, THE ORIGINAL PRODUCT HAS NOT BEEN RECEIVED. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD THE ORIGINAL PRODUCT BE RECEIVED RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. 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

    THE CUSTOMER REPORTED THAT HER PHYSICIAN TOLD HER SHE HAD MASTITIS AND THAT THE MASTITIS COULD HAVE BEEN CAUSED BY CONTAMINATION FROM MILK BACKING UP INTO HER PUMP IN STYLE BREAST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645827 PUMP IN STYLE ADVANCED BREASTPUMP STARTER HGX HGX MEDELA INC. 57081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other