BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

    MDR report key: 6137793 · Received December 1, 2016

    Report

    Report Number
    1419937-2016-00309
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 8, 2016
    Report Date
    December 1, 2016
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP IN STYLE ADVANCED BREAST PUMP. ON 11/17/2016, A MEDELA CLINICIAN FOLLOW UP WITH THE CUSTOMER AT TIME SHE STATED SHE WAS ON A PRESCRIPTION MEDICATION FOR 10 DAYS BUT SHE CANNOT REMEMBER THE NAME OF IT. SHE ALSO STATED THAT HER REPLACEMENT PUMP IS WORKING WELL AND SHE IS NOT HAVING ANY SIGNS OR SYMPTOMS OF MASTITIS. 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 PRODUCT WAS RECEIVED AND EVALUATED BY QUALITY ENGINEERING ON 11/23/2016. THE EVALUATION FOUND THAT A MEMBRANE AND VALVE WERE DAMAGED, HOWEVER THE UNIT PASSED ALL FUNCTIONAL TESTS. SEE ATTACHED PRODUCT EVALUATION.

    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 BREAST PUMP WAS LOW. SHE ALSO REPORTED THAT HER DOCTOR DIAGNOSED HER WITH MASTITIS AND PRESCRIBED HER WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789516 PUMP IN STYLE ADVANCED - ON-THE-GO TOTE PUMP, BREAST, POWERED HGX MEDELA, INC 57063 426367

    Patients

    Seq Age Sex Outcome Treatment
    1 Other