BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 8151871 · Received December 11, 2018

    Report

    Report Number
    1419937-2018-00262
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 19, 2018
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDELA LLC IS FILING THIS CORRECTION AFTER RECEIVING ADDITIONAL INFORMATION IN AN EMAIL FROM THE CUSTOMER ON 02/11/2019, IN WHICH SHE INDICATED SHE HAD USED OVER THE COUNTER LECITHIN FOR HER CLOGGED DUCTS, NOT PRESCRIPTION MEDICATION. THE CLOGGED DUCTS DID NOT REQUIRE MEDICAL ATTENTION, THEREFORE THE ORIGINAL REPORT WHICH WAS FILED WAS NOT REQUIRED.

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING 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 "CLANGING" NOISE REPORTED BY THE CUSTOMER WAS NOT HEARD DURING TROUBLESHOOTING AND THE SUCTION ISSUE COULD NOT BE RESOLVED THROUGH TROUBLESHOOTING. A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/ANALYSIS. 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 (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION, WAS MAKING A "CLANGING" NOISE, AND WAS NOT WORKING AS WELL AS HER FRIEND'S PUMP IN STYLE WHICH SHE HAD USED. SHE ADDITIONALLY ALLEGED THAT SHE WAS GETTING CLOGGED DUCTS WEEKLY, WENT TO THE DOCTOR AND WAS GIVEN MEDICATION TO HELP WITH THE CLOGGED DUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992044 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA LLC 57081 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other