BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND PRS 10CM X 15CM SEMI

    MDR report key: 7980943 · Received October 18, 2018

    Report

    Report Number
    3004170064-2018-00007
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    September 25, 2018
    Report Date
    September 25, 2018
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K083898
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON: "BOTH SURGIMENDS USED IN BREAST RECONSTRUCTION OVER TISSUE EXPANDERS ON (B)(6) 2018. PATIENT HAD SEROMA BILATERALLY LONGER THAN WITH ALLEDERM (BOTH SIDES). THE LEFT SIDE WOUND BROKE DOWN OVER SURGIMEND ON (B)(6) 2018. "SURGIMEND" SEEN NOT TO BE INCORPORATED. IMPLANT EXPOSED. ON THE RIGHT SIDE, INFECTION AND THINNING OF TISSUE WAS BEGINNING AT INCISION SITE ON (B)(6) 2018. NEITHER SURGIMENDS EXPANDED WELL FROM DAY 1" PROCEDURE: IMMEDIATE BREAST RECONSTRUCTION WITH TISSUE EXPANDER.

    Additional Manufacturer Narrative · 0

    NO PRODUCT LOT NUMBER WAS PROVIDED WITH THIS COMPLAINT THEREFORE DHR REVIEW CANNOT BE PERFORMED. THE ONLY PRODUCT INFORMATION PROVIDED IN THE COMPLAINT WAS THAT THE PRODUCT IMPLANTED WAS SURGIMEND. ADDITIONALLY, LOTS RELEASED TO THE MARKET BY INTEGRA LIFESCIENCES MEET RELEASE ACCEPTANCE CRITERIA FOR ALL REQUIRED INSPECTIONS AND TESTS. WHILE A SPECIFIC LOT NON-CONFORMANCE QUERY COULD NOT BE PERFORMED FOR THIS COMPLAINT, ANY NON-CONFORMANCES THAT OCCUR ARE INVESTIGATED UPON DISCOVERY AND PRODUCT IMPACT ASSESSMENT AND RISK ASSESSMENT ARE DETERMINED FOR ANY AFFECTED LOTS. ROOT CAUSE IS INDETERMINABLE AND THE FAILURE IS UNCONFIRMED, AS THERE WAS NO PRODUCT RETURNED FOR THIS COMPLAINT. THEREFORE, FAILURE ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 0

    DHR; NO ANOMALIES FOUND IN THE AFOREMENTIONED DOCUMENTS AND THERE IS NO INDICATION THAT THE MANUFACTURING OR FINAL PACKAGING/LABELING PROCESSES MAY HAVE CONTRIBUTED TO THIS COMPLAINT. FINISHED GOODS LOTS RELEASED TO THE MARKET BY INTEGRA MEET FINISHED GOODS RELEASE ACCEPTANCE CRITERIA FOR ALL REQUIRED INSPECTIONS AND TESTS.

    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) 2018, A SURGIMEND MATRIX WAS USED FOR A BREAST RECONSTRUCTION CASE. IT WAS NOTED THAT THERE WERE NO INCORPORATION OF THE PRODUCT AND THE PATIENT HAD IMPLANT EXPOSURE 3 MONTHS POST-OP. BILATERAL PROCEDURE HAD TO BE CONDUCTED TO ADDRESS THE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819026 SURGIMEND PRS 10CM X 15CM SEMI SURGIMEND FTM TEI BIOSCIENCES INC 1602023

    Patients

    Seq Age Sex Outcome Treatment
    1