BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BREASTPUMP

    MDR report key: 9793539 · Received March 5, 2020

    Report

    Report Number
    1419937-2020-00018
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    February 7, 2020
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    UDI-DI
    00020451330921
    PMA / PMN Number
    K150499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDELA LLC CUSTOMER SERVICE REFERRED THE CUSTOMER TO MEDELA (B)(4) CUSTOMER SERVICE. ON 02/11/2020, MEDELA (B)(4) CUSTOMER SERVICE CONTACTED THE CUSTOMER AND SHE INDICATED THAT SHE WAS USING A 24MM BREAST SHIELD ON ONE SIDE AND A 27MM BREAST SHIELD ON THE OTHER SIDE, AS RECOMMENDED BY HER LACTATION CONSULTANT. ADDITIONALLY, SHE INDICATED THAT SHE CLEANED HER KIT PARTS WITH WARM SOAPY WATER, BUT HAD NEVER SANITIZED THEM. SHE STATED THAT SHE HAD BEEN ABLE TO USE A MEDELA SYMPHONY BREAST PUMP UPON BIRTH SUCCESSFULLY AND HER BABY WAS TAKING THE BREAST WELL, BUT WHILE PUMPING WITH THE FREESTYLE BREAST PUMP FOR 20 MINUTES SHE HAD ONLY EXPRESSED 15ML COMBINED. SHE ALSO INDICATED SHE HAD SEEN A DOCTOR BECAUSE OF THE PAIN FROM PUMPING AND HAD BEEN PRESCRIBED A CREAM. MEDELA (B)(4) CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING DISASSEMBLING, INSPECTING, CLEANING AND REASSEMBLING THE KIT AND TUBING SET; AND VERIFYING BREAST SHIELD FIT. THE TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE CUSTOMER WAS SENT A REPLACEMENT PUMP, A BREAST SHIELD SIZER, AND A ONE MONTH ACCESS CODE FOR THE MEDELA 24/7 LC BREASTFEEDING SUPPORT APPLICATION. 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. 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 02/07/2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE BREAST PUMP HAD LOW SUCTION AND HER NIPPLES WERE BURNING AFTER PUMPING, DUE TO NOT BEING ABLE TO PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254623 FREESTYLE BREASTPUMP PUMP, BREAST, POWERED HGX MEDELA AG 27260 ASKU 00020451330921

    Patients

    Seq Age Sex Outcome Treatment
    1 Other