BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, BREAST, POWERED

    MDR report key: 2017848 · Received March 10, 2011

    Report

    Report Number
    1419937-2011-00018
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 7, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN F/U WITH THE CUSTOMER, SHE INDICATED THAT SHE WAS NOT EXPRESSING AS MUCH MILK AS SHE DID WITH A PREVIOUS PUMP, THAT PUMPING WAS PAINFUL AND HER BREASTS WERE RED AND IRRITATED. SHE STATED THAT SHE TRIED DIFFERENT BREAST SHIELD SIZES AND TYPES AND IT DID NOT RESOLVE THE ISSUE. SHE SAW A PHYSICIAN ON (B)(6) 2011 BECAUSE SHE FELT A LUMP IN HER BREAST. THE DR DIAGNOSED IT AS A CLOGGED DUCT THAT DEVELOPED INTO A CYST, WHICH COULD BE RELATED TO THE FACT THAT SHE IS NOT EXPRESSING ALL OF THE BREAST MILK FROM HER BREASTS. THE DR RECOMMENDED THAT SHE USE TREATMENT PACKS AND MASSAGING TO DRAIN THE CYST. MEDICATIONS WERE NOT PRESCRIBED; HOWEVER, THE CUSTOMER INDICATED THAT SHE WOULD ALSO BE CONSULTING A SPECIALIST. MEDELA SENT THE CUSTOMER A REPLACEMENT PUMP. THE PUMP IDENTIFIED IN THE COMPLAINT WAS RETURNED FOR EVAL/ANALYSIS. IN SUMMARY, THE PUMP FUNCTIONED PROPERLY THROUGHOUT THE EXPERIMENT AND DID NOT FAIL TO PERFORM ITS INTENDED FUNCTION. THE VACUUM LEVEL AT THE MAXIMUM SETTING IN STIMULATION PHASE WHILE DOUBLE PUMPING WAS BELOW THE SPECIFIED LIMIT. HOWEVER, IT SHOULD BE NOTED THAT THE PUMP WAS NOT DESIGNED TO EXPRESS MILK DURING STIMULATION PHASE BUT WAS DESIGNED TO INDUCE LET DOWN DURING THIS PHASE. THE CUSTOMER ALSO RETURNED BREAST SHIELDS WHICH WERE VISUALLY INSPECTED AND NO ABNORMALITIES WERE IDENTIFIED. EVAL SUMMARY: THE PUMP WAS VISUALLY EXAMINED AND THE FOLLOWING WERE NOTED: PUMP TYPE: PUMP IN STYLE ADVANCED. PUMP MFG ON: 1/20/2011 (B)(4). CIRCUIT BOARD DATE: (B)(4); SOFTWARE VERSION 5.2; (B)(4); LOT CODE 0334 (1). AC ADAPTER MEDELA PART #9200043. VACUUM LEVELS WERE MEASURED USING A KEYENCE GAUGE AND CYCLE COUNTS WERE DETERMINED BY COUNTING THE NUMBER OF CYCLES OVER A ONE MINUTE PERIOD AS MEASURED WITH A STOP WATCH (NOTE: THE PUMP RAN FOR 30 SECONDS BEFORE ANY MEASUREMENTS WERE TAKEN). (B)(4). THE PUMP FUNCTIONED PROPERLY THROUGHOUT THE EXPERIMENT AND DID NOT FAIL TO PERFORM ITS INTENDED FUNCTION. THE VACUUM LEVEL AT THE MAXIMUM SETTING IN STIMULATION PHASE WHILE DOUBLE PUMPING WAS BELOW THE SPECIFIED LIMIT. THE BREAST SHIELDS (24 MM PERSONAL FIT) WERE VISUALLY INSPECTED AND FELT FOR ANY SHARP EDGES OR DEFORMATION. NONE EXISTED; BOTH BREAST SHIELDS APPEARED TO BE IN PROPER WORKING ORDER. (B)(4). MEDELA HAS BEEN UNABLE TO GET IN CONTACT WITH THE CUSTOMER FOR F/U REGARDING HER VISIT WITH A SPECIALIST AND TO DETERMINE THE CURRENT STATUS OF HER ISSUE, INCLUDING HOW THE REPLACEMENT PUMP IS WORKING FOR HER. ATTEMPTS TO CONTACT THE CUSTOMER WILL CONTINUE. SHOULD ADD'L INFO BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE EXPERIENCED NIPPLE PAIN FROM THE MOMENT SHE GOT HER NEW PUMP AND THAT SHE MAY NOW HAVE A CLOGGED DUCT IN HER LEFT BREAST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other