BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BREASTPUMP

    MDR report key: 2033384 · Received March 24, 2011

    Report

    Report Number
    1419937-2011-00046
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    January 3, 2010
    Report Date
    January 10, 2011
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LARGER BREAST SHIELDS WERE SENT TO THE CUSTOMER. THE CUSTOMER WAS CONTACTED BY QUALITY ON (B)(6) 2011 FOR ADDITIONAL INFORMATION. PER THE CUSTOMER, WHILE USING THE FREESTYLE, SHE WAS NOT GETTING MILK OUT AND DEVELOPED MASTITIS. SHE WENT TO THE DOCTOR WHO PRESCRIBED ANTIBIOTICS, AND THE MASTITIS CLEARED UP. A (B)(6) CLINICIAN ALSO SPOKE TO THE CUSTOMER ((B)(6) 2011 CLINICIAN CONVERSATION). THE CUSTOMER INDICATED THAT THE LARGER BREAST SHIELDS SENT BY CUSTOMER SERVICE ALLOWED FOR BREAST EMPTYING, BUT SHE STILL WANTED TO REPLACE THE PUMP AND USE ONLY THE HOSPITAL PUMP (DIFFERENT BRAND). THE CUSTOMER CONFIRMED SHE WAS NO LONGER EXPERIENCING SYMPTOMS, AND IS NO LONGER USING THE FREESTYLE PUMP. AN INITIAL EVALUATION OF THE COMPLAINT AND FOLLOW-UP INFORMATION WAS PERFORMED ON (B)(6) 2011 AND DETERMINED THE COMPLAINT WAS NOT REPORTABLE AT THAT TIME. THE ORIGINAL PUMP WAS RETURNED ON (B)(6) 2011 AND GIVEN TO ENGINEERING FOR EVALUATION. THE PUMP FUNCTIONED PROPERLY THROUGHOUT THE EXPERIMENT. ANOTHER REVIEW OF THE COMPLAINT INFORMATION AND PRODUCT EVALUATION WAS PERFORMED. THIS EVENT IS BEING REPORTED AT THIS TIME SINCE THE CUSTOMER REPORTED MASTITIS, AND THERE IS NO DEFINITIVE EVIDENCE THE PUMP DID OR DID NOT CONTRIBUTE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER USING HER PUMP FOR APPROXIMATELY A WEEK AND A HALF AGO, "IT IS VERY PAINFUL AND IT IS PINCHING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BREASTPUMP HGX MEDELA AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other