BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUGLU SURGICAL ADHESIVE

    MDR report key: 6312754 · Received February 8, 2017

    Report

    Report Number
    3012970114-2017-00001
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 10, 2017
    Report Date
    February 8, 2017
    Manufacturer
    COHERA MEDICAL INC
    Product Code
    PJK
    UDI-DI
    M690TG100US0
    PMA / PMN Number
    P130023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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) 2016. ON (B)(6) 2017, THE DOCTOR INFORMED COHERA THAT HE PERFORMED A REVISION SURGERY BECAUSE HE OBSERVED EXTRUSION OF TISSUGLU® THROUGH THE INCISION LINE. THE REPORTED 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." 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
    94083 TISSUGLU SURGICAL ADHESIVE TISSUGLU PJK COHERA MEDICAL INC TG100US CM0332 M690TG100US0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other