BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2181381 · Received July 21, 2011

    Report

    Report Number
    1419937-2011-00151
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER VIA E-MAIL IN AN EFFORT TO GET ADDITIONAL INFO REGARDING THE ISSUE THAT SHE WAS EXPERIENCING AND TO MAKE ARRANGEMENTS TO REPLACE THE PUMP. THE CUSTOMER WOULD ONLY INDICATE IN ONE E-MAIL RESPONSE THAT SHE "GOT INJURED USING THE ADVANCED BREAST PUMP AND [SHE IS] LOOKING FOR SOMEONE IN THE UPPER MANAGEMENT, PRESIDENT OR VICE-PRESIDENT, THAT [SHE] CAN SEND ALL [HER] INFO TO WHO CAN HELP [HER] OUT" AND IN ORDER ANOTHER E-MAIL RESPONSE THAT SHE WAS "ADVISED BY [HER] LAWYER NOT TO HAVE ANY COMMUNICATION AT THIS TIME." NEITHER ADDITIONAL COMPLAINT INFO NOR THE PUMP WERE RECEIVED FROM THE CUSTOMER AS OF THE DATE OF THIS REPORT. BASED ON THE LIMITED COMPLAINT INFO AND THE FACT THAT THE PUMP IS NOT AVAILABLE FOR TESTING AND ANALYSIS, IT CANNOT BE DEFINITIVELY CONCLUDED THAT IT CAUSED OR CONTRIBUTED TO THE INJURY. WE WILL CONTINUE TO TRY TO GET ADDITIONAL COMPLAINT INFO AND TO GET THE PRODUCT BACK FOR TESTING/ANALYSIS. SHOULD ADDITIONAL INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER POSTED THE FOLLOWING ON FACEBOOK: "WHO DID YOU SPEAK TO? I AM TRYING TO GET MY ISSUE RESOLVED AND THEY KEEP TELLING ME SOMEONE WILL CALL ME, BUT IT HAS BEEN OVER A WEEK AND I HAVE NOT RECEIVED ANY CALL. HOW CAN I GET SOME SERVICE? NEVER HAD THIS FROM ANY COMPANY THAT I HAVE PURCHASED PRODUCTS FROM. THANKS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other