BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APDP BASE BP EN ES USA

    MDR report key: 8443430 · Received March 22, 2019

    Report

    Report Number
    1419937-2019-00046
    Event Type
    Injury
    Date Received
    March 22, 2019
    Date of Event
    March 1, 2019
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING POWERING THE DEVICE ON WITH THE POWER SUPPLY, INSPECTING THE FACEPLATE AND BACK PLATE FOR DAMAGE; INSPECTING AND CLEANING THE DIAPHRAGM; DISASSEMBLING, INSPECTING, CLEANING AND REASSEMBLING THE KIT AND TUBING SET; AND VERIFYING BREAST SHIELD FIT. THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. THE CUSTOMER WAS CONTACTED BY A COMPLAINT HANDLER ON MULTIPLE OCCASIONS, INCLUDING IN WRITING, TO GET ADDITIONAL INFORMATION, WITH NO RESPONSE AS OF THE DATE OF THIS REPORT. THE DEVICE WAS RETURNED WITH THE CUSTOMER'S PARTS AND ACCESSORIES AND WAS EVALUATED ON 03/20/2019. THE DEVICE PASSED SUCTION AND CYCLE SPECIFICATIONS, THOUGH IT WAS IDENTIFIED IN THE EVALUATION THAT THE CUSTOMER'S VALVES AND CONNECTORS WERE DIRTY. REFER TO ATTACHED EVALUATION. THE CUSTOMER'S REPORT OF LOW SUCTION COULD NOT BE CONFIRMED. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATION WAS PRESCRIBED).

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WAS LOSING SUCTION. THE CUSTOMER INDICATED THAT SHE SINGLE PUMPS ONE SIDE AT A TIME AND SHE USED TO GET 3 OUNCES IN 5 MINUTES PER SIDE, BUT IT IS NOW TAKING HER 10 MINUTES. THE CUSTOMER ADDITIONALLY ALLEGED THAT SHE HAD CLOGGED DUCTS FOR WHICH SHE WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238519 APDP BASE BP EN ES USA PUMP, BREAST, POWERED HGX MEDELA LLC 101035078 448568

    Patients

    Seq Age Sex Outcome Treatment
    1 Other