BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BP ADVANCED PERSONAL DOUBLE

    MDR report key: 3874805 · Received June 2, 2014

    Report

    Report Number
    1419937-2014-00447
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN A FOLLOW UP WITH THE CUSTOMER, THE CUSTOMER STATED THAT THEY WOULD SHIP THE ORIGINAL PRODUCT BACK. AS OF THE DATE OF THIS REPORT, THE ORIGINAL PRODUCT HAS NOT BEEN RECEIVED. 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. THE CAUSE OF THE BREACH IN THE REV N TRANSFORMER HAS NOT BEEN DETERMINED AT THIS TIME. IT IS CURRENTLY BEING INVESTIGATED UNDER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HOUSING FOR THEIR PUMP IN STYLE POWER ADAPTER FELL COMPLETELY APART, WHICH IS A SAFETY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321032 BP ADVANCED PERSONAL DOUBLE HGX MEDELA, INC. 57065/9207010 3113 / REV N

    Patients

    Seq Age Sex Outcome Treatment
    1