BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 3919124 · Received June 16, 2014

    Report

    Report Number
    1121308-2014-00021
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    November 20, 2012
    Report Date
    May 23, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    KGN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED AS PART OF A STUDY CONDUCTED TITLED: (B)(4), THIS REPORT CONCERNS THE EVENT OF "DEHISCENCE." THE SUBJECT RECEIVED INTEGRA AND NEGATIVE PRESSURE WOUND THERAPY (NPWT) ON (B)(6) 2012. THE SUBJECT'S WOUND, WHICH WAS ON THE LEFT LATERAL ANKLE, HAD AN ETIOLOGY OF ISCHEMIC/DIABETIC NEUROPATHIC ULCER. THE WOUND'S APPROXIMATE MEASUREMENT WAS 4 CM LENGTH X 6 CM WIDTH. ON (B)(6) 2012 SUBJECT WAS READMITTED FOR A SCHEDULED SPLIT THICKNESS SKIN GRAFT (STSG) + NPWT. ON (B)(6) 2012 THE SUBJECT EXPERIENCED AN ADVERSE EVENT OF "DEHISCENCE." THIS EVENT WAS DOCUMENTED AS MODERATE IN SEVERITY AND POSSIBLY RELATED TO THE INITIAL INDEX TREATMENT WITH INTEGRA. THE ACTION TAKEN WAS RECEIPT OF CONCOMITANT MEDICATIONS/THERAPY (NOT SPECIFIED). THE EVENT WAS DEEMED RESOLVED ON (B)(6) 2013 WHEN THE SUBJECT RETURNED FOR A FOLLOW-UP VISIT AND THE WOUND WAS HEALED. THE WOUND RECURRED AGAIN ON (B)(6) 2013 BUT NO ADDITIONAL FOLLOW-UP WAS PROVIDED REGARDING THIS EVENT. THE PRECISE INTEGRA PRODUCT ID AND A LOT NUMBER WERE REQUESTED BY INTEGRA LIFESCIENCES FOR THE INTEGRA PRODUCT THAT WAS APPLIED. THE CLINICAL SITE REPORTED THEY REVIEWED THE DICTATED OPERATIVE REPORT AND DISCHARGE SUMMARY FROM THAT HOSPITAL VISIT, AND NEITHER DOCUMENT CONTAINED THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352507 NONE NONE KGN INTEGRA LIFESCIENCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention