BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2181379 · Received July 21, 2011

    Report

    Report Number
    1419937-2011-00150
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE SENT A REPLACEMENT PUMP TO THE CUSTOMER. AT INITIAL RECEIPT OF THE CUSTOMER REPORT, THERE WAS NO INDICATION OF A REPORTABLE ISSUE. HOWEVER, IN FOLLOW UP WITH THE CUSTOMER ON (B)(6) 2011 TO FIND OUT WHAT WAS NOT WORKING ON THE PUMP, SHE INDICATED THAT THE PUMP WAS NOT PULLING AT HER BREAST AND SHE COULD NOT ACHIEVE LET DOWN. SHE USED IT FOR 2-3 MONTHS AND THEN STOPPED PUMPING AND GOT MASTITIS TWO TIMES. SHE SAW A DOCTOR WHO PRESCRIBED ANTIBIOTICS WHICH RESOLVED THE MASTITIS BOTH TIMES. SHE IS NO LONGER USING THE PUMP BUT IS CONTINUING TO BREAST FEED HER BABY. SHE ALSO INDICATED THAT THE REPLACEMENT PUMP WORKS FINE AND SHE DOES NOT CURRENTLY HAVE 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." THOUGH ATTEMPTS WERE MADE TO GET THE PUMP BACK FOR TESTING/ANALYSIS, IT HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. BASED ON THE FACT THAT THE PUMP IS NOT AVAILABLE FOR TESTING/ANALYSIS, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE MASTITIS. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE HAD BEEN RENTING A BREAST PUMP FOR THE LAST NINE MONTHS AND RECENTLY PURCHASED A PUMP AND DOES NOT FEEL LIKE IT WORKS ADEQUATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE BREAST PUMP HGX MEDELA, INC. 57062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other