BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS PERICARDIAL PATCH

    MDR report key: 3882259 · Received June 18, 2014

    Report

    Report Number
    2015691-2014-01401
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXZ
    PMA / PMN Number
    K082139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THIS PRODUCT WAS RECEIVED BY THE CUSTOMER WITH THE SEAL BROKEN ON THE PACKAGING. UNFORTUNATELY, THE ISSUE COULD NOT BE CONFIRMED THROUGH EVALUATION OF THE DEVICE, AS IT WAS NOT RETURNED IN THE CONDITION AS REPORTED. THE ORIGINAL PRODUCT PACKAGING WAS NOT PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THE CUSTOMER RECEIVED A PERICARDIAL PATCH WITH THE "SEAL BROKEN" ON THE PACKAGING. THE CUSTOMER ALSO COMMENTED THAT THE "CAP WASN'T SCREWED ON TIGHT." THE PRODUCT WAS NOT USED AND RETURNED TO EDWARDS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358536 EDWARDS PERICARDIAL PATCH PERICARDIAL PATCH DXZ EDWARDS LIFESCIENCES 4700 R-13B0526

    Patients

    Seq Age Sex Outcome Treatment
    1