BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE

    MDR report key: 1963765 · Received December 22, 2010

    Report

    Report Number
    1419937-2010-00093
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PURCHASED A REPLACEMENT POWER CORD, FOR WHICH WE REIMBURSED HER. IN FOLLOW UP DISCUSSIONS WITH THE CUSTOMER REGARDING THE ORIGINAL POWER CORD, SHE INDICATED THAT SHE SAW NO FIRE OR SPARKING, BUT THAT THERE WAS A SMALL HOLE MELTED INTO THE TRANSFORMER CASING. THE CUSTOMER INDICATED THAT SHE RETURNED THE ORIGINAL POWER CORD, BUT IT HAS NOT YET BEEN RECEIVED. AS THE ORIGINAL PRODUCT IS NOT AVAILABLE FOR EVAL/ ANALYSIS, NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT CAN BE MADE. SHOULD THE PRODUCT BECOME AVAILABLE, AN EVAL WILL BE PERFORMED AND A SUPPLEMENTAL MEDWATCH SUBMITTED AT THAT TIME IF APPLICABLE. (B)(4), APPROVED ON (B)(4) 2010, HAS BEEN INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/ MELTING ISSUES. ANY ADDITIONAL FOLLOW UP ACTIONS WILL BE ESTABLISHED AS A RESULT OF THE CAPA PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER USING HER PUMP FOR 4 MONTHS, THE POWER CORD GOT VERY HOT AND MELTED WHEN SHE PLUGGED THE PUMP IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE NONE HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1