BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN PLUS DURAL REGENERATION MATRIX 2X2 1 PA

    MDR report key: 3137051 · Received May 28, 2013

    Report

    Report Number
    1121308-2013-00015
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    March 31, 2013
    Report Date
    May 28, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    GXQ
    PMA / PMN Number
    K032693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    IT WAS REPORTED THAT THE REGISTERED NURSE (RN) COMPLETED A CHART REVIEW ON THE DURAGEN AND FOUND THAT THIS PATIENT HAD A FEVER IN THE IMMEDIATE POSTOPERATIVE PERIOD USING THEIR HOSPITAL CRITERIA. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(4) 2013, THE FOLLOWING INFORMATION WAS RECEIVED: ONE QUANTITY OF DURAGEN (PRODUCT ID (B)(4) WITH LOT NUMBER 1125526) WAS IMPLANTED IN THE PATIENT ON (B)(6) 2013 DURING A LUMBAR SPINAL FUSION. THE FEVER CRITERIA USED BY THE USER FACILITY WAS REPORTED AS A TEMPERATURE OF 100.4 DEGREES FAHRENHEIT OR GREATER. THE PATIENT'S TEMPERATURE READINGS WERE ON: (B)(6) 2013 = 101.1 F, ON (B)(6) 2013 = 101.1 F, ON (B)(6) 2013 = 100.3 F, ON (B)(6) 2013 = 100.1 F, ON (B)(6) 2013 = 101.0 F, AND ON (B)(6) 2013 = NO FEVER. THE PATIENT DID NOT HAVE ANY FEVER PRIOR TO THE SURGERY AND/OR IMPLANTATION OF THE DURAGEN. NO CULTURES WERE TAKEN. NO SPECIFIC TREATMENT WAS GIVEN TO THE PATIENT FOR THE FEVER. HOWEVER, AS PER PROTOCOL FOR THE SURGERY, THE PATIENT WAS GIVEN ANTIBIOTICS AFTER THE SURGERY. THE PATIENT WAS ALSO GIVEN TYLENOL FOR PAIN. PATIENT OUTCOME WAS REPORTED AS GOOD AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON 03/07/2013 WITHOUT ANY FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233536 DURAGEN PLUS DURAL REGENERATION MATRIX 2X2 1 PA NA GXQ INTEGRA LIFESCIENCES CORP. 1125526

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other