BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BP ADVANCED PERSONAL DOUBLE

    MDR report key: 4218754 · Received October 30, 2014

    Report

    Report Number
    1419937-2014-00817
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 27, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT VEHICLE ADAPTER 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 SUCKING INFANT. THE RISK OF MASTITIS IS HIGHER AMONG WOMEN WHO HAVE BREASTFED PREVIOUSLY, ESPECIALLY THOSE WITH A HISTORY OF 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. 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 BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE WAS HAVING LOW SUCTION WHEN USING THE VEHICLE LIGHTER ADAPTER WITH HER ADVANCED PERSONAL DOUBLE BREAST PUMP. SHE VISITED HER OB/GYN AND IS ON AN ANTIBIOTIC FOR MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697497 BP ADVANCED PERSONAL DOUBLE HGX MEDELA, INC. 67174/57065

    Patients

    Seq Age Sex Outcome Treatment
    1 Other