BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2844397 · Received November 16, 2012

    Report

    Report Number
    1419937-2012-00736
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 20, 2012
    Report Date
    October 20, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP IN STYLE. IN FOLLOW UP WITH THE CUSTOMER ON (B)(4) 2012, THE CUSTOMER INDICATED THAT HER MILK EXPRESSION HAD DECREASED SUDDENLY AND SHE BELIEVED THAT THE PUMP IN STYLE DEVICE THAT SHE WAS USING HAD LOWER SUCTION. SHE DID CONSULT HER HEALTHCARE PROVIDER WAS DIAGNOSED WITH MASTITIS AND WAS PRESCRIBED CEPHALEXIN, AN ANTIBIOTIC. SHE ALSO STATED THAT THE MASTITIS WAS MUCH IMPROVED AFTER TAKING THE ANTIBIOTIC. THE CUSTOMER WAS ALSO CONTACTED BY A MEDELA CLINICIAN ON (B)(4) 2012. THE CUSTOMER REPORTED TO THE CLINICIAN THAT THE MASTITIS WAS CLEARING UP AND THAT THE REPLACEMENT PUMP SHE RECEIVED FROM MEDELA WAS WORKING WELL. "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 OF MASTITIS." ["BREASTFEEDING AND HUMAN LACTATION" (RIORDAN AND WAMBACH, 4TH EDITION, PAGE 294)]. THE BREAST PUMP WAS RETURNED BY THE CUSTOMER FOR TESTING/ANALYSIS. BASED ON THE FACT THAT THE PUMP TESTED TO SPECIFICATION, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE MASTITIS. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES. SHOULD ADDITIONAL INFORMATION BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED. EVALUATION SUMMARY: THE PUMP IN STYLE DEVICE WAS RETURNED FOR TESTING WITH THE KIT, BUT NO MEMBRANES. THE PUMP WAS TESTED, NO PROBLEMS WERE FOUND. THE PUMP WAS FOUND TO BE WITHIN VACUUM SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS EXPERIENCING LOW MILK EXPRESSION AND THAT SHE WAS DIAGNOSED WITH MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED HGX MEDELA, INC. 57063 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1