BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE HANDS-FREE BREASTPUMP

    MDR report key: 7036428 · Received November 16, 2017

    Report

    Report Number
    1419937-2017-00321
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    October 26, 2017
    Report Date
    February 26, 2018
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K150499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITH THE CUSTOMER'S PARTS AND ACCESSORIES AND WAS EVALUATED ON (B)(6) 2018, AND THE DEVICE FAILED SUCTION AND CYCLE SPECIFICATIONS. A LEAK ON THE SEALING SURFACE OF THE CUSTOMER'S CONNECTOR WAS IDENTIFIED DURING THE PRODUCT EVALUATION. THE DEVICE WAS THEN RE-EVALUATED ON (B)(6) 2018 USING A MEDELA KIT, AND IT PASSED SUCTION AND CYCLE SPECIFICATIONS. REFER TO ATTACHED EVALUATION. THE ROOT CAUSE OF THE LOW SUCTION ISSUE WITH THE CUSTOMER'S PARTS CAN BE ATTRIBUTED TO A MOLDING DEFICIENCY ON THE CONNECTORS SEALING SURFACE. CURRENTLY THERE IS AN OPEN INVESTIGATION (B)(4), WHICH IDENTIFIED MOLDING ENHANCEMENTS TO CORRECT THIS DEFICIENCY WHICH WERE PUT IN PLACE IN (B)(6) OF 2017.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND HER PUMP WAS REQUESTED FOR RETURN. MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER TO GET ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE, BUT ARE ON-GOING. THOUGH THE COMPLAINT INFORMATION DOES NOT REASONABLY SUGGEST THAT THE MEDELA DEVICE CAUSED OR CONTRIBUTED TO THE INJURY OR THAT THE DEVICE MALFUNCTIONED, MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (SURGERY TO REMOVE ABSCESS).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE BREAST PUMP WAS NOT EXPRESSING HER MILK AND SHE HAD SURGERY DUE TO AN ABSCESS WHICH DEVELOPED. SHE REPORTED THAT SHE HAD BACTERIA IN THE MILK THAT SHE COULDN¿T PULL OUT, WHICH GAVE HER AN INFECTION. SHE COULD HAND EXPRESS AND USE A HOSPITAL GRADE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816437 FREESTYLE HANDS-FREE BREASTPUMP PUMP, BREAST, POWERED HGX MEDELA AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other