BEUDAMED
    FDA Adverse Event Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

    MDR report key: 3032573 · Received March 29, 2013

    Report

    Report Number
    1419937-2013-00180
    Date Received
    March 29, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER SUPPLY. ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT WERE UNSUCCESSFUL, INCLUDING A FINAL ATTEMPT BY LETTER. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT AT THIS TIME. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES, A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PUMP IN STYLE TRANSFORMER WAS PLUGGED INTO AN OUTLET AND BECAME VERY HOT AND THE BACK OF THE HOUSING HAD A SMALL HOLE MELTED IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130275 PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG HGX MEDELA INC 57036/9207010 17H

    Patients

    Seq Age Sex Outcome Treatment
    1