BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDRT-TS (INTL) 5 PACK 4X5

    MDR report key: 3181508 · Received June 17, 2013

    Report

    Report Number
    1121308-2013-00019
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    MGR
    PMA / PMN Number
    P900033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(4) 2013. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. EVAL OF THE COMPLAINT RELATED DEVICE WAS NOT PERFORMED AS THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE MFG RECORDS WAS PERFORMED WHICH REVEALED: ALL MFG EQUIPMENT UNDERWENT STERILIZATION AT THE REQUIRED TEMP AND TIME CONDITIONS. THE FOIL AND TYVEK POUCH SEALING CONDITIONS AND TEST RESULTS WERE REVIEWED AND MET REQUIREMENTS. PRODUCT ENDOTOXIN AND PRE-STERILE BIOBURDEN TESTS MET REQUIREMENTS. ENVIRONMENTAL MONITORING RESULTS MET REQUIREMENTS. THE PRODUCT LOTS TERMINAL STERILIZATION RESULTS WERE REVIEWED AND THE RADIATION DOSES MET REQUIREMENTS. ALL FINISHED GOOD REQUIREMENT WERE SATISFACTORILY MET. THEREFORE, BASED ON THE DHR REVIEW CONDUCTED, THERE IS NO INDICATION THAT THE PRODUCTION PROCESS MAY HAVE CONTRIBUTED TO THIS COMPLAINT. REVIEW OF COMPLAINT HISTORY: THERE WERE 15 INFECTION RELATED COMPLAINTS FOR IDRT-TS, IDRT-SL, BMW AND MWM SKIN PRODUCTS IN THE PREVIOUS 12 MONTHS. NONE OF THESE OTHER COMPLAINTS INVOLVED THE LOT GENEALOGY OF THIS COMPLAINT. (B)(4). NOTE THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT GENEALOGY; THIS COMPLAINT APPEARS TO BE AN ISOLATED EVENT. CONCLUSION: BASED ON REVIEW OF THE BATCH RECORD, NONCONFORMANCES, TRENDING AND COMPLAINT HISTORY, NO ROOT CAUSE ATTRIBUTABLE TO THE MFG PROCESS COULD BE IDENTIFIED THROUGH THIS INVESTIGATION. IN ADDITION, THE PRODUCT WAS NOT RETURNED FROM THE FIELD; THEREFORE, NO FAILURE ANALYSIS OF THE PRODUCT COULD BE CONDUCTED. BASED ON THE REPORTED INFO AND THE INVESTIGATION RESULTS PROVIDED. INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS ENROLLED IN A CLINICAL STUDY IN (B)(4) TITLED: EVAL OF INTEGRA ARTIFICIAL DERMIS FOR THE TREATMENT OF LEG ULCERS. IDRT WAS IMPLANTED ON (B)(6) 2012 ON THE PT'S LEFT POSTERIOR LEG ULCER. ON (B)(6) 2012, THE GRAFT WAS CHECKED AND A LOCALIZED INFECTION (ACINETOBACTER WHICH WAS MULTI-RESISTANT) WAS OBSERVED. TREATMENT WITH (UNSPECIFIED) ANTIBIOTICS WAS PROVIDED AND THE INFECTION RESOLVED "DUE TO ANTIBIOTICS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273001 IDRT-TS (INTL) 5 PACK 4X5 IDRT-TS MGR INTEGRA LIFESCIENCES CORP. 105B00246903

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention