BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUGLU SURGICAL ADHESIVE

    MDR report key: 6105061 · Received November 15, 2016

    Report

    Report Number
    3006559785-2016-00001
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 15, 2016
    Manufacturer
    COHERA MEDICAL INC
    Product Code
    PJK
    PMA / PMN Number
    P130023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE PATIENT RECEIVED FOLLOW-UP TREATMENT WITH RESPECT TO ALLEGED CONTINUED COMPLICATIONS ASSOCIATED WITH AN ABDOMINOPLASTY SURGERY USING TISSUGLU(R) SURGICAL ADHESIVE IN CONJUNCTION WITH STANDARD OF CARE. THE HEALTHCARE PROFESSIONAL PRESCRIBED ANTIBIOTICS FOR THE ALLEGED COMPLICATION ON (B)(6) 2017.

    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) 2015. AT AN UNKNOWN DATE, THE PATIENT ALLEGEDLY DEVELOPED A SMALL OPENING ON HER ABDOMEN WHICH DISCHARGED FLUID AND EXPELLED PIECE(S) OF CURED TISSUGLU SURGICAL ADHESIVE . IT WAS FURTHER REPORTED THAT ON (B)(6) 2016, THE PATIENT'S SURGEON CONDUCTED AN ADDITIONAL SURGICAL PROCEDURE TO CLEAN AND CLOSE THE ABDOMINAL OPENING. THE PATIENT IS CURRENTLY BEING TREATED FOR MINOR COMPLICATIONS ASSOCIATED WITH THE ADDITIONAL SURGICAL PROCEDURE. THE REPORTED OPENING ON THE ABDOMEN 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754493 TISSUGLU SURGICAL ADHESIVE TISSUGLU PJK COHERA MEDICAL INC TG100US CM0332

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention