BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUGLU SURGICAL ADHESIVE

    MDR report key: 6866959 · Received September 14, 2017

    Report

    Report Number
    3012970114-2017-00003
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    August 16, 2017
    Report Date
    September 14, 2017
    Manufacturer
    COHERA MEDICAL INC
    Product Code
    PJK
    PMA / PMN Number
    P130023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PHYSICIAN THE PATIENT IDENTIFIED IN THIS REPORT HAS ALLEGEDLY HAD ADDITIONAL CURED ADHESIVE EXTRUSION FROM THE SUTURE LINE WHICH OCCURRED BETWEEN SEPTEMBER (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    ON MAY 8, 2018 IT WAS REPORTED THAT THE PATIENT HAS ALLEGEDLY CONTINUED TO LEAK FLUID AND MINUTE PIECES OF RESIDUAL GLUE FROM THE INCISION LINE. THE PATIENT AND PHYSICIAN HAVE PLANNED TO PERFORM A REVISION TO REMOVE THE RESIDUAL ADHESIVE FROM THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE COMPANY BY A HEALTHCARE PROFESSIONAL THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY SURGERY USING TISSUGLU SURGICAL ADHESIVE IN CONJUNCTION WITH STANDARD OF CARE ON (B)(6) 2017. ON (B)(6) 2017, THE SURGEON INFORMED COHERA THAT SHE PERFORMED AN IRRIGATION AND DEBRIDEMENT PROCEDURE TO ADDRESS A WOUND LOCATED ON THE PATIENT'S RECONSTRUCTED UMBILICAL SKIN. ON (B)(6) 2017, ADDITIONAL INFORMATION WAS PROVIDED TO THE COMPANY THAT ALLEGEDLY THE PATIENT CONTINUED TO LEAK BLOOD AND PIECES OF A FOREIGN BODY (ASSUMED TO BE REMNANTS OF CURED TISSUGLU® SURGICAL ADHESIVE) THROUGH HER SUTURE LINE. THE PATIENT APPEARS TO HAVE EXPERIENCED AN INSTANCE OF TISSUGLU EXTRUSION. THE REPORTED OPENING ON THE SUTURE LINE AND EXTRUSION OF TISSUGLU® SURGICAL ADHESIVE FRAGMENTS IS CONSISTENT WITH KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ABDOMINOPLASTY SURGERIES AND IS DESCRIBED AS A PRECAUTION IN THE TISSUGLU SURGICAL ADHESIVE DIRECTIONS FOR USE (DFU-100-0001): "CONSIDERATION SHOULD BE TAKEN IN THE USE OF TISSUGLU®, AS THERE IS A POSSIBILITY THAT CURED TISSUGLU® MAY BE EXTRUDED SIMILAR TO SUTURE EXTRUSION. THE PATIENT IS CURRENTLY BEING TREATED FOR MINOR COMPLICATIONS ASSOCIATED WITH THE ADDITIONAL SURGICAL PROCEDURE. IT IS NOT ANTICIPATED THAT THE EXISTENCE OR EXPULSION OF TISSUGLU WILL PRESENT ANY ADVERSE REACTION, INFECTION, OR OTHER HEALTH CONSEQUENCE ASSOCIATED WITH THE EXPULSION OF THE TISSUGLU FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646520 TISSUGLU SURGICAL ADHESIVE TISSUGLU PJK COHERA MEDICAL INC TG100US CM0340

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention