BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNSA STARTER BP EN ES USA

    MDR report key: 9700180 · Received February 12, 2020

    Report

    Report Number
    1419937-2020-00009
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    January 21, 2020
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451350776
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 INDICATED THAT SHE WAS PRESCRIBED A CREAM BY HER PHYSICIAN TO HELP WITH BLISTERING THAT OCCURRED AS A RESULT OF THE ISSUE. SHE CONSULTED WITH A LACTATION CONSULTANT AND IS NOW USING 30MM BREAST SHIELDS, BUT FEELS THAT 32MM WOULD BE BETTER. SHE REPORTED THAT HER BREAST SHIELD SIZING ISSUE IS "KIND OF RESOLVED." SHE REQUESTED TO HAVE A MEDELA LACTATION CONSULTANT CONTACT HER. A MEDELA CLINICIAN FOLLOWED UP WITH THE CUSTOMER AS REQUESTED ON (B)(6) 2020. THE CUSTOMER INDICATED THAT HER PUMP WAS WORKING BETTER, BUT SHE STILL HAS SOME DISCOMFORT WITH THE BREAST SHIELDS AND STILL HAS A SMALL BLISTER ON ONE BREAST. SHE ASKED FOR A RECOMMENDATION ON SIZING. ON (B)(6) 2020, THE CLINICIAN LEFT A VOICEMAIL AND EMAILED THE CUSTOMER BREAST SHIELD SIZING TIPS AND ASKED THE CUSTOMER TO FOLLOW UP WITH HER IF SHE NEEDED FURTHER ASSISTANCE. AS OF THE DATE OF THIS REPORT, THE CUSTOMER HAS NOT DONE SO. THE DEVICE WAS RETURNED WITH THE CUSTOMER'S PARTS AND ACCESSORIES AND WAS EVALUATED ON (B)(6) 2020. THE DEVICE PASSED SUCTION AND CYCLE SPECIFICATIONS AND PASSED POWER TESTING. NO ISSUES WERE FOUND WITH THE CUSTOMER'S 27MM BREAST SHIELDS. REFER TO PRODUCT EVALUATION. THE CUSTOMER'S REPORT OF THE PUMP POWERING OFF COULD NOT BE CONFIRMED. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATION WAS PRESCRIBED). THE INSTRUCTIONS FOR USE PROVIDES INSTRUCTIONS FOR BREAST SHIELD SIZING, INCLUDING REFERENCE TO MEDELABREASTSHIELDS.COM AND REFERRAL TO A LACTATION CONSULTANT FOR ASSISTANCE IN CHOOSING THE CORRECT SIZE BREAST SHIELD.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP POWERS DOWN WHILE IN USE. SHE ADDITIONALLY ALLEGED THAT THE 27MM BREAST SHIELDS THAT SHE WAS USING WERE RUBBING AND CAUSING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165321 PNSA STARTER BP EN ES USA PUMP, BREAST, POWERED HGX MEDELA LLC 101035077/8107176 457007 00020451350776

    Patients

    Seq Age Sex Outcome Treatment
    1 Other