BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE ORIGINAL

    MDR report key: 1880471 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00027
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY LIMITED INFORMATION WAS PROVIDED AT THE TIME OF CUSTOMER CONTACT (NO PRODUCT NUMBER, CUSTOMER LAST NAME, PHONE NUMBER, E-MAIL). NO PRODUCT WAS RETURNED FOR EVALUATION. AS NO CUSTOMER CONTACT INFORMATION WAS RELEASED, NO ATTEMPTS TO FOLLOW-UP CAN BE CONDUCTED. THEREFORE, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AC ADAPTER BLEW UP. CUSTOMER INDICATED THE PUMP STILL WORKS WITH BATTERIES. PUMP IS 10 MONTHS OLD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other