BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE HANDS-FREE BREASTPUMP

    MDR report key: 6966614 · Received October 20, 2017

    Report

    Report Number
    1419937-2017-00294
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    March 31, 2017
    Report Date
    January 10, 2018
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K150499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THE EVENT IS ON-GOING.

    Additional Manufacturer Narrative · 1

    THOUGH THE DEVICE WAS NOT RETURNED FOR EVALUATION, A PRODUCT EVALUATION WAS CONDUCTED ON 12/05/2017 AT A LOCATION SPECIFIED BY THE CUSTOMER'S ATTORNEY AS FOLLOWS: A CONTROL PUMP WITH A CONTROL KIT WERE TESTED AT MEDELA LLCS LOCATION. THE CONTROL PUMP WITH THE CONTROL KIT PASSED VACUUM AND CYCLE SPECIFICATIONS. THE SAME CONTROL PUMP WITH THE CONTROL KIT WERE RETESTED AT THE ATTORNEY'S LOCATION TO VERIFY THAT THE PERFORMANCE REMAINED CONSISTENT WITH THE INITIAL DATA. AGAIN, THE CONTROL PUMP WITH THE CONTROL KIT PASSED VACUUM AND CYCLE SPECIFICATIONS. THE CUSTOMER PUMP WITH THE CUSTOMER KIT WERE VISUALLY INSPECTED AND TESTED AT THE ATTORNEY'S LOCATION. DRIED RESIDUE WAS OBSERVED ON THE KIT COMPONENTS, AS WELL AS BLACK DUST UNDER THE BACK HOUSING COVER. THE CUSTOMER PUMP WITH THE CUSTOMER KIT FAILED LOW VACUUM SPECIFICATIONS. THE CUSTOMER PUMP WITH THE CONTROL KIT WERE TESTED AT THE ATTORNEY'S LOCATION. THE CUSTOMER PUMP WITH THE CONTROL KIT PASSED VACUUM AND CYCLE SPECIFICATIONS. THE CONTROL PUMP WAS TESTED WITH THE CUSTOMER KIT AT THE ATTORNEY'S LOCATION. THE CONTROL PUMP WITH THE CUSTOMER KIT AT THE ATTORNEY'S LOCATION. THE CONTROL PUMP WITH THE CUSTOMER KIT FAILED LOW VACUUM SPECIFICATIONS. BASED ON THE RESULTS OF THE TESTING, IT IS REASONABLE TO CONCLUDE THAT THE LOW VACUUM CONDITION RELATED TO THE CUSTOMER'S PUMP WAS THE RESULT OF DRIED RESIDUE ON THE KIT COMPONENTS.

    Description of Event or Problem · 1

    THE FOLLOWING IS A SUMMARY OF A COMMUNICATION RECEIVED BY MEDELA LLC ON (B)(6) 2017 FROM A THIRD PARTY REGARDING AN EVENT WHICH OCCURRED ON (B)(6) 2017 INVOLVING A FREESTYLE BREAST PUMP.  THE COMMUNICATION DID NOT ALLEGE A SPECIFIC PUMP MALFUNCTION.  MEDELA LLC HAS NOT RECEIVED ANY INFORMATION TO VERIFY OR VALIDATE THE  ALLEGED EVENT AND/OR INJURY. A CUSTOMER PURCHASED A FREESTYLE BREAST PUMP ON (B)(6) 2013 AND USED IT WITHOUT ISSUE  WITH HER FIRST CHILD.  THE CUSTOMER USED THE PUMP AGAIN WITH SECOND CHILD STARTING AROUND (B)(6) 2016 FOR 10 MONTHS WHEN, ON (B)(6) 2017, SHE SUDDENLY EXPERIENCED A SHARP PAIN AND LOOKED DOWN AND SAW THAT THE PUMP  BOTTLE WAS BEGINNING TO FILL WITH BLOOD.  SHE IMMEDIATELY TURNED OFF THE PUMP AND GENTLY  REMOVED THE BREAST SHIELD TO FIND THAT HER LEFT NIPPLE WAS BADLY RUPTURED IN TWO PLACES,  EXPOSING SUBCUTANEOUS TISSUE, BLEEDING PROFUSELY AND CAUSING SIGNIFICANT PAIN.  SHE  CONTACTED HER PHYSICIAN HUSBAND AS WELL AS HER LACTATION CONSULTANT.  DESPITE SEEKING  TREATMENT, HER INJURIES LEFT HER UNABLE TO CONTINUE BREASTFEEDING OR USING A BREAST PUMP AND SHE WAS FORCED TO DISCONTINUE PROVIDING BREAST MILK AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744495 FREESTYLE HANDS-FREE BREASTPUMP PUMP, BREAST, POWERED HGX MEDELA AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other