BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURA NO-REACT DURAL SUBSTITUTE, 2CM X 10CM

    MDR report key: 893450 · Received August 10, 2007

    Report

    Report Number
    3003418325-2007-00010
    Event Type
    Injury
    Date Received
    August 10, 2007
    Date of Event
    May 1, 2006
    Report Date
    August 10, 2007
    Manufacturer
    SHELHIGH
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US

    Narratives

    Additional Manufacturer Narrative · 1

    CO IS FILING A DISTRIBUTOR REPORT BASED UPON INFO PROVIDED BY THE USER FACILITY. CORRESPONDENCE SHOULD BE SENT TO DISTRIBUTOR: CORPORATE COMPLAINT COORDINATOR. THE MFR HAS BEEN NOTIFIED OF THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM TECHNICAL SERVICES ON 7/17/2007. THE PHYSICIAN CALLED TO REPORT AN INCIDENT HAD OCCURRED AT THE USER FACILITY. A MEDWATCH FORM 3500 WAS SUBMITTED ON THE FOLLOWING DAY RESPONDING TO THE ENDURA RECALL. THE INCIDENT OCCURRED IN 2006. THE LOT NUMBER PROVIDED WAS MISSING ONE DIGIT. LOT GENEOLOGY INDICATED THE USER FACILITY ORDERED THE PRODUCT LOT NUMBER 040405NRA. THE MEDWATCH FROM INDICATES THE PATIENT DEVELOPED A POST OP WOUND INFECTION TWICE SINCE THE OPERATION TO TREAT FOR SYRINGOMYELIA. INFECTIONS WERE CULTURED ON THE SAME DAY AND STAPHYLOCOCCUS AUREUS WAS IDENTIFIED. UNKNOWN IF INFECTION RELATED TO GRAFT. ENDURA WAS NEVER REMOVED. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND IS SEEN AS AN OUTPATIENT. THE MEDWATCH REPORT WAS RECEIVED ON 7/18/2007 STATING PATIENT RECEIVED ENDURA GRAFT, POST OP WOUND INFECTION. UNKNOWN IF RELATED TO GRAFT, STAPH AUREUS. PATIENT WAS TREATED FOR SYRINGOMYELIA ON THE DATE OF INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURA NO-REACT DURAL SUBSTITUTE, 2CM X 10CM NONE GXQ SHELHIGH 040405NRA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization