BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAGEN 3X3 1 PACK DOMESTIC

    MDR report key: 1592144 · Received February 1, 2010

    Report

    Report Number
    1121308-2010-00005
    Event Type
    Other
    Date Received
    February 1, 2010
    Date of Event
    January 19, 2010
    Report Date
    February 1, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PRODUCT WAS IMPLANTED IN ERROR INTO A PATIENT DURING A CRANIOTOMY FOR A BRAIN TUMOR. THE EXPIRATION DATE THAT WAS PRINTED ON THE DEVICE LABEL WAS OCTOBER 2009. THE PRODUCT WAS SENT TO THE HOSPITAL IN (B)(6) 2007 AND WAS PART OF THE HOSPITAL INVENTORY. THE HOSPITAL OPERATING ROOM STAFF DID NOT CHECK THE EXPIRATION DATE ON THE PRODUCT LABEL. THE EVENT WAS NOTICED A DAY OR TWO LATER DURING MAINTENANCE OF THE HOSPITAL'S IMPLANT LOG. THERE HAS BEEN NO REPORT OF A RELATED ADVERSE OUTCOME FOR THE PATIENT TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGEN 3X3 1 PACK DOMESTIC NA GXQ INTEGRA LIFESCIENCES CORP. 1062356

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other STABILIZATION| STRYKER/LEIBINGER PLATES FOR CRANIAL FLAP