BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRT-TS 8X10 5 PACK DOMESTIC

    MDR report key: 2182594 · Received July 5, 2011

    Report

    Report Number
    1121308-2011-00026
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    May 24, 2011
    Report Date
    July 5, 2011
    Manufacturer
    INTEGRA, PLAINSBORO
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN EVALUATED. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PRODUCT PACKAGING WAS STAINED BROWN ON THE INSIDE WHERE IT SHOULD HAVE BEEN STERILE. THE PRODUCT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDRT-TS 8X10 5 PACK DOMESTIC IDRT-TS GXQ INTEGRA, PLAINSBORO 105B00165833

    Patients

    Seq Age Sex Outcome Treatment
    1