BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2051253 · Received April 6, 2011

    Report

    Report Number
    1419937-2011-00059
    Event Type
    Injury
    Date Received
    April 6, 2011
    Report Date
    March 8, 2011
    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

    CUSTOMER SERVICE SENT A REPLACEMENT PUMP TO THE CUSTOMER. DURING A CLINICAL ASSESSMENT OF THE COMPLAINT, THE CUSTOMER WAS CONTACTED FOR ADD'L INFO. THE CUSTOMER INDICATED THAT SHE HAD BEEN PUMPING FOR PREMATURE TWIN INFANTS AND DEVELOPED MASTITIS WHILE USING THE PUMP. SHE VISITED A PHYSICIAN, WHO DIAGNOSED HER WITH MASTITIS AND PRESCRIBED AN ANTIBIOTIC (X10 DAYS), WHICH RESOLVED THE MASTITIS. "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. IN SUMMARY, THE PUMP PERFORMED ITS INTENDED FUNCTION AND IT MET ITS PERFORMANCE SPECS. BASED ON THE FACT THAT THE PUMP WAS NOT OUT OF SPEC, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE MASTITIS. WE WILL MONITOR COMPLAINT FOR SIMILAR ISSUES. EVAL SUMMARY: THE PUMP WAS VISUALLY EXAMINED AND THE FOLLOWING WERE NOTED: PUMP TYPE: PUMP IN STYLE ADVANCED. PUMP MFG ON: 01/13/2011 ON WORK ORDER # (B)(4). CIRCUIT BOARD DATA: MEDELA PART #9007040A; MFR PART # W541; LOT CODE 0349 (1); SOFTWARE VERSION 5.2. AC ADAPTER MEDELA PART # 9207010. VACUUM LEVELS WERE MEASURED USING A KEYENCE GAUGE AND CYCLE COUNTS WERE DETERMINED BY COUNTING THE NUMBER OF CYCLES OVER A ONE MINUTE PERIOD AS MEASURED WITH A STOP WATCH AND THE FOLLOWING WERE THE RESULTS (NOTE: THE PUMP RAN FOR 30 SECONDS BEFORE ANY MEASUREMENTS WERE TAKEN). VACUUM AND CYCLE SPECS FOR THE PUMP ARE AS FOLLOWS: THE PUMP FUNCTIONED PROPERLY THROUGHOUT THE EXPERIMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE WAS PUMPING FOR PREMATURE TWINS BUT STOPPED BECAUSE SHE DEVELOPED MASTITIS AND "OTHER PROBLEMS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1