BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TCC-EZ CASE OF 10 CASTING SYSTEMS 3" NO BOOT

    MDR report key: 10275696 · Received July 15, 2020

    Report

    Report Number
    9680091-2019-00011
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    October 23, 2019
    Report Date
    November 6, 2019
    Manufacturer
    DERMA SCIENCES, INC.
    Product Code
    ITG
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DEFINITE ROOT CAUSE CANNOT BE IDENTIFIED AS NO LOT# WAS PROVIDED AND NO PRODUCT WAS RETURNED BASED FROM THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED, HOWEVER, TO GUARANTEE THE PERFORMANCE OF THE PRODUCT, PROPER PREPARATION AND APPLICATION OF THE CAST SHOULD BE FOLLOWED. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA (B)(4) HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(4) OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    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 THAT ON (B)(6) 2019, THE TCC-EZ CAST BUCKLED AT THE ANTERIOR ANKLE, CAUSING A DEEP TISSUE INJURY ON THE DORSUM OF THE FOOT. THE CAST WAS REMOVED, THE INJURY WAS ASSESSED AND COVERED FOR PROTECTION WITH NO CAST REPLACEMENT UNTIL THE RESOLUTION. THE TREATMENT PERFORMED WAS PRESSURE REDUCTION/PREVENTION. THE CAST WAS PLACED TO TREAT A DIABETIC FOOT ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741214 TCC-EZ CASE OF 10 CASTING SYSTEMS 3" NO BOOT TCC-EZ ITG DERMA SCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1