BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

    MDR report key: 6004619 · Received October 6, 2016

    Report

    Report Number
    1419937-2016-00260
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    August 29, 2016
    Report Date
    September 19, 2016
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT BREAST PUMP WAS SENT TO THE CUSTOMER. ON (B)(6) 2016, A MEDELA CLINICIAN FOLLOW UP WITH THE CUSTOMER AT WHICH TIME SHE STATED THAT HER OBSTETRICIAN DIAGNOSED HER WITH MASTITIS ON (B)(6) 2016 AND PRESCRIBED AMOXICILLIN FOR 10 DAYS. SHE ALSO STATED THAT THE MASTITIS IS CLEARED UP AT THIS 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. THE DEVICE WAS RECEIVED ON (B)(4) 2016 AND EVALUATED BY QUALITY ENGINEERING, THE EVALUATION RESULTS WERE NOT ABLE TO DUPLICATE THE CUSTOMER'S COMPLAINT OF LOW SUCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE SUCTION ON HER PUMP IN STYLE ADVANCED WAS LOW AND THAT SHE HAD A BREAST INFECTION, BUT DID NOT REPORT OF ANY DIAGNOSIS OR PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657018 PUMP IN STYLE ADVANCED - ON-THE-GO TOTE PUMP, BREAST, POWERED HGX MEDELA, INC 57063 429895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other