BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 4936639 · Received July 23, 2015

    Report

    Report Number
    1419937-2015-00235
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 23, 2015
    Manufacturer
    MEDELA INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION ARE ONGOING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE 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.

    Additional Manufacturer Narrative · 1

    THE ORIGINAL DEVICE WAS EVALUATED BY A QUALITY ENGINEER ON 2/2/2016. THE CUSTOMER'S COMPLAINT CANNOT BE CONFIRMED. THE UNIT FUNCTIONED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS EXPERIENCING HIGH SUCTION WITH HER PUMP IN STYLE BREAST PUMP. SHE STATED THAT HER NIPPLES WERE CRACKED AND BLEEDING AND THAT SHE HAD EXPERIENCED CLOGGED DUCTS. THE CUSTOMER ALSO REPORTED THAT SHE HAD MASTITIS AND WAS PRESCRIBED KEFLEX, AN ANTIBIOTIC, BY HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479811 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX HGX MEDELA INC. 57063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other