BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND PRS MESHED 20CM X 10CM X 1MM

    MDR report key: 10278171 · Received July 15, 2020

    Report

    Report Number
    3004170064-2020-00001
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    December 15, 2019
    Report Date
    January 31, 2020
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K171357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE IS INDETERMINABLE. NO LOT NUMBER WAS PROVIDED IN THE COMPLAINT DOCUMENTATION, THEREFORE DHR REVIEW COULD NOT BE CONDUCTED. THE ONLY INFORMATION PROVIDED WAS THE PRODUCT NAME, SURGIMEND PRS. THE DEVICE WAS NOT RETURNED FOR FAILURE ANALYSIS. IF THE DEVICE IS RETURNED LATER, AND LOT INFORMATION PROVIDED, THIS COMPLAINT WILL BE REOPENED, AND ROOT CAUSE ANALYSIS WILL BE CONDUCTED AS APPLICABLE. BETWEEN (B)(6) 2019 AND (B)(6) 2020, 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 (B)(6). 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 (B)(6) 2019 THROUGH (B)(6) 2020. INTEGRA LIFESCIENCES CONTACTED (B)(6), DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6), ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON (B)(6) 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SURGIMED PLACEMENT FOR A BREAST RECONSTRUCTION, THE PATIENT HAD A GRAM NEGATIVE INFECTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739134 SURGIMEND PRS MESHED 20CM X 10CM X 1MM SURGIMEND FTM TEI BIOSCIENCES INC

    Patients

    Seq Age Sex Outcome Treatment
    1