BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWING CANADA/AG

    MDR report key: 8840731 · Received July 30, 2019

    Report

    Report Number
    1419937-2019-00099
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    July 9, 2019
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDELA (B)(4) CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, DISASSEMBLING, INSPECTING, CLEANING AND REASSEMBLING THE KIT AND TUBING SET; AND VERIFYING BREAST SHIELD FIT. THE CUSTOMER WAS CONTACTED BY A MEDELA (B)(4) COMPLAINT HANDLER TO GET ADDITIONAL INFORMATION, WITH NO RESPONSE AS OF THE DATE OF THIS REPORT. 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 SHE WAS EXPERIENCING LOW SUCTION WITH HER SWING BREAST PUMP. SHE FURTHER ALLEGED THAT HER DOCTOR PUT HER ON MEDICATION BECAUSE HER PUMP WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634993 SWING CANADA/AG PUMP, BREAST, POWERED HGX MEDELA AG 27276

    Patients

    Seq Age Sex Outcome Treatment
    1 Other