BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUGLU SURGICAL ADHESIVE

    MDR report key: 7042163 · Received November 17, 2017

    Report

    Report Number
    3012970114-2017-00004
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    April 19, 2017
    Report Date
    November 17, 2017
    Manufacturer
    COHERA MEDICAL, INC
    Product Code
    PJK
    PMA / PMN Number
    P130023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE COMPANY ON (B)(6) 2017 THAT A PATIENT WHO HAD UNDERWENT AN ABDOMINOPLASTY SURGERY USING TISSUGLU® SURGICAL ADHESIVE IN CONJUNCTION WITH STANDARD OF CARE ON (B)(6) 2017 HAD A MINOR COMPLICATION ON (B)(6) 2017. ON (B)(6) 2017 THE SURGEON NOTIFIED COHERA MEDICAL THAT THE PATIENT HAD REQUIRED A PROCEDURE TO OPEN A RAISED SURFACE AREA, DESCRIBED AS AN ABSCESS, ALONG THE INCISION LINE. ON (B)(6) 2017 THE RAISED SURFACE AREA WAS OPENED, BY THE PHYSICIAN, USING A MINOR PROCEDURE IN THE OR AND AN ALLEGED SMALL AMOUNT OF RESIDUAL TISSUGLU® SURGICAL ADHESIVE WAS REMOVED USING FORCEPS. THE REPORTED CONDITION ON THE ABDOMEN CAN BE A PRECURSOR TO EXTRUSION AND THEREFORE IS CONSISTENT WITH KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ABDOMINOPLASTY SURGERIES AND IS DESCRIBED AS A PRECAUTION IN THE TISSUGLU SURGICAL ADHESIVE DIRECTIONS FOR USE ((B)(4)): "CONSIDERATION SHOULD BE TAKEN IN THE USE OF TISSUGLU®, AS THERE IS A POSSIBILITY THAT CURED TISSUGLU® MAY BE EXTRUDED SIMILAR TO SUTURE EXTRUSION. FURTHER COMMUNICATION ON (B)(6) 2017 BETWEEN COHERA AND THE PHYSICIAN AND STAFF FIND THAT THE PATIENT'S CONDITION WAS RESOLVED AND REQUIRED NO ADDITIONAL INTERVENTION AFTER THE ADDITIONAL PROCEDURE PERFORMED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820602 TISSUGLU SURGICAL ADHESIVE TISSUGLU PJK COHERA MEDICAL, INC TG100US CM0337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention