BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 2896541 · Received December 31, 2012

    Report

    Report Number
    1419937-2012-00847
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    September 22, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE SENT THE CUSTOMER A REPLACEMENT BREAST PUMP. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT WHEN USING THE BREAST PUMP, SHE FELT LIKE HER "NIPPLES WERE RIPPING OFF." SHE ORIGINALLY PURCHASED THE PUMP IN 2009 AND USED IT THEN FOR 5 MONTHS WITHOUT ISSUE. SHE STARTED USING THE PUMP AGAIN IN (B)(6) 2012 TO FEED HER (B)(6) BABY HER BREAST MILK. SHE PUMPED UP TO AS MANY AS TEN TIMES PER DAY. SHE BEGAN TO HAVE ISSUES WITH THE PUMP AFTER APPROXIMATELY ONE TO TWO DAYS OF PUMPING. HER NIPPLES BECAME "SEVERELY TRAUMATIZED AND SHE HAD TRAUMATIC RAYNAUD'S SYNDROME. SHE SAW A PHYSICIAN AND FOUR LACTATION CONSULTANTS A TOTAL OR APPROXIMATELY TEN TIMES. HER NIPPLES HEALED ONLY AFTER SWITCHING FROM THE 30 MM BREAST SHIELDS TO THE 36 MM USING (B)(6) MULTIPLE TIMES A DAY, SWITCHING TO A RENTED HOSPITAL GRADE PUMP, TAKING VITAMINS AND BREAST FEEDING MORE FREQUENTLY THAN PUMPING. SHE INDICATED THAT THE REPLACEMENT PUMP THAT WAS SENT TO HER IS WORKING WITHOUT ISSUE. SHE INDICATED THAT THERE IS NO ON-GOING ADVERSE EFFECT. THE PUMP WAS RECEIVED AND EVALUATED. THE EVALUATION INDICATED THAT THE PUMP WAS PERFORMING WITHIN VACUUM AND CYCLE COUNT SPECIFICATIONS. AS A RESULT, THE CAUSE OF THE CUSTOMER'S ISSUE CANNOT BE DETERMINED AND IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED, OR CONTRIBUTED TO, THE CUSTOMER'S ISSUE. THIS CUSTOMER'S ISSUE MAY HAVE BEEN THE RESULT OF BREAST SHIELD SIZING. EVALUATION SUMMARY: THE PUMP WAS VISUALLY EXAMINED AND THE FOLLOWING WERE NOTED: PUMP TYPE: PUMP IN STYLE ITEM #(B)(4); MANUFACTURED 04/23/2009; UNIT WAS RETURNED WITH THE TRANSFORMER; HOWEVER, OTHER BREAST PUMP KIT AND ACCESSORIES WERE NOT RETURNED. VACUUM LEVELS AND CYCLE RATES WERE MEASURED USING THE CUSTOMER'S RETURNED TRANSFORMER'S RETURNED TRANSFORMER AND LAB ACCESSORIES AND PUMP KIT. VACUUM AND CYCLE SPECIFICATIONS FOR THE PUMP AS FOUND IN THE DESIGN HISTORY FILE ARE AS FOLLOWS: SEE SCANNED TABLE. THE VACUUM TESTS PERFORMED MEET THE TEST CRITERIA DOCUMENTED IN THE DESIGN HISTORY FILE. NOTE 1 - VACUUM AND CYCLE RATES WERE MEASURED USING VACUUM/CYCLE FIXTURE (ID# (B)(4)), CALIBRATION EXPIRES 07/23/2013.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SUCTION ON HER 2009 BREAST PUMP IS "WAY TOO HIGH, EVEN ON THE LOWEST SETTING." SHE HAS SEEN MULTIPLE LACTATION CONSULTANT'S FOR BREAST SHIELD SIZING AND HAS CHANGED BREAST SHIELD SIZE TO HELP ALLEVIATE THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other