BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

    MDR report key: 7032416 · Received November 15, 2017

    Report

    Report Number
    1419937-2017-00319
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 20, 2017
    Report Date
    November 14, 2017
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN FOLLOW UP WITH THE CUSTOMER ON (B)(6) 2017, THE CUSTOMER RESPONDED THAT SHE STARTED USING THE PUMP IN STYLE IN (B)(6) DUE TO HER DAUGHTER HAVING REFLUX, AND THE ISSUE WITH PAIN FOLLOWED SHORTLY AFTER. SHE STATED THAT, IN ALL FAIRNESS, SHE HAD A CUT FROM HER DAUGHTER NURSING AND BLISTERS CAME SHORTLY AFTER. SHE WAS PRESCRIBED A MEDICATED LOTION TO HEAL HER NIPPLES. TO DATE SHE HAS NOT CALLED BACK TO TROUBLESHOOT THE ISSUE SHE REPORTED WITH THE PUMP. THOUGH THE COMPLAINT INFORMATION DOES NOT REASONABLY SUGGEST THAT OUR DEVICE CAUSED OR CONTRIBUTED TO THE INJURY OR THAT THE DEVICE MALFUNCTIONED, MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATED LOTION).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC THAT IT HURTS WHEN SHE PUMPS WITH HER PUMP IN STYLE BREAST PUMP ON THE FIRST PHASE, BUT NOT ON THE SECOND PHASE. SHE USES THE PUMP AT MINIMUM VACUUM IN THE FIRST PHASE, BUT THEN WHEN THE PUMP SWITCHES TO THE SECOND PHASE, SHE CAN TURN IT UP A BIT MORE, ALMOST TO HALFWAY. SHE REPORTED THAT SHE FEELS THAT THE PUMP SEEMS TO WORK BETTER (IT IS STRONGER AND GETS MORE MILK OUT) WITH THE VEHICLE LIGHT ADAPTER RATHER THAN WITH THE POWER SUPPLY, SO SHE WAS INQUIRING ON WHERE TO PURCHASE A NEW POWER SUPPLY. THE CUSTOMER DID NOT HAVE THE PUMP WITH HER AT THE TIME OF THE CALL AND STATED THAT SHE WOULD CALL BACK TO TROUBLESHOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812229 PUMP IN STYLE ADVANCED - ON-THE-GO TOTE PUMP, BREAST, POWERED HGX MEDELA LLC 57063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other