BEUDAMED
    FDA Adverse Event Summary report: N

    PERCUTANEOUS SHEATH INTRODUCER KIT

    MDR report key: 3566507 · Received January 9, 2014

    Report

    Report Number
    2015691-2014-00077
    Date Received
    January 9, 2014
    Date of Event
    December 11, 2013
    Report Date
    December 11, 2013
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQY
    PMA / PMN Number
    K831729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE ABLE TO EVALUATE THE SHIPPING DAMAGE FROM PHOTOS SENT BY DHL. EXAMINATION OF THE PHOTOS FOUND THE CORNER OF THE OUTER CARDBOARD CORRUGATED BOX HAS BEEN CRUSHED AND RIPPED OPEN AND THE DAMAGE EXTENDING DOWN THE SIDE OF THE BOX. THE PRODUCT INSIDE OF THE BOX WAS DAMAGED AND THAT THE STERILITY OF THE PRODUCT HAD BEEN COMPROMISED. ADDITIONAL INFORMATION WILL BE FORTHCOMING AS RECEIVED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    AS REPORTED, THE CARTON WAS TORN. DAMAGED PRODUCTS WERE NOTICED INSIDE OF THE CARTON. THE STERILITY OF THE DEVICES IS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17623 PERCUTANEOUS SHEATH INTRODUCER KIT CATHETER, PERCUTANEOUS DQY EDWARDS LIFESCIENCES PR I650BF85 59605816

    Patients

    Seq Age Sex Outcome Treatment
    1