BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNSA STARTER BP EN ES USA

    MDR report key: 10516831 · Received September 10, 2020

    Report

    Report Number
    1419937-2020-00100
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    August 20, 2020
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451350776
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2020, THE CUSTOMER CONFIRMED THAT SHE WAS PRESCRIBED AN ANTIBIOTIC AND ANTI-FUNGAL CREAM. SHE WAS OFFERED TO SPEAK WITH A MEDELA CLINICIAN AND ACCEPTED. FOLLOW UP WITH THE CLINICIAN IS ON-GOING 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) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SUCTION WAS TOO HIGH ON HER PUMP IN STYLE BREAST PUMP WHEN SET AT THE LOWEST VACUUM SETTING. SHE ADDITIONALLY ALLEGED THAT IT CAUSED THE BLOOD VESSELS IN HER NIPPLES TO BURST AND TURN PURPLE. SHE WAS GIVEN AN ANTIBIOTIC AND ANTI-FUNGAL CREAM. SHE INDICATED THAT SHE WENT BACK TO USING A SYMPHONY BREAST PUMP WITH NO ISSUES, BUT WHEN TRYING THE PUMP IN STYLE AGAIN, IT ONCE AGAIN CAUSED THE BLOOD VESSELS IN HER NIPPLES TO BURST AND TURN PURPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979773 PNSA STARTER BP EN ES USA PUMP, BREAST, POWERED HGX MEDELA LLC 101035077 0000002893 00020451350776

    Patients

    Seq Age Sex Outcome Treatment
    1 Other