BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDRT-TS (INTL) SINGLE 4X5

    MDR report key: 2802358 · Received October 19, 2012

    Report

    Report Number
    1121308-2012-00032
    Event Type
    Injury
    Date Received
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    MGR
    PMA / PMN Number
    P900033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER NOTED THE PT WAS ENROLLED IN A CLINICAL STUDY IN (B)(6) TITLED: "EVAL OF INTEGRA ARTIFICIAL DERMIS FOR THE TREATMENT OF LEG ULCERS. THE PT UNDERWENT IMPLANTATION OF IDRT ON (B)(6) 2011, ON A MIXED ULCER. THE PT DEVELOPED A LOCAL INFECTION ON (B)(6) 2011, UNDER THE SILICONE (POSITIVE FOR PSEUDOMONAS "AERUGOSIMA" AND E COLI). ANTIBIOTIC TREATMENT AND WASHING WERE PROVIDED. THE INFECTION SUBSIDED ON (B)(6) 2011. THE PT DEVELOPED A NEW INFECTION ON (B)(6) 2011, WITH LYSIS OF THE GRAFT AT 80%. TREATMENT WAS PROVIDED WITH A DIFFERENT DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDRT-TS (INTL) SINGLE 4X5 IDRT-TS MGR INTEGRA LIFESCIENCES CORP. 105C00207932

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention