BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUGLU SURGICAL ADHESIVE

    MDR report key: 7183869 · Received January 11, 2018

    Report

    Report Number
    3012970114-2018-00001
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    November 17, 2017
    Report Date
    January 11, 2018
    Manufacturer
    COHERA MEDICAL INC
    Product Code
    PJK
    PMA / PMN Number
    P130023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE COMPANY BY DR. (B)(6) THAT A PATIENT UNDERWENT ABDOMINOPLASTY SURGERY USING TISSUGLU SURGICAL ADHESIVE IN CONJUNCTION WITH STANDARD OF CARE ON (B)(6) 2017. ON (B)(6) 2017, THE SURGEON REPORTED THAT THE PATIENT HAD PRESENTED WITH A SKIN RASH IN THE AREA OF TREATMENT AND REQUESTED INFORMATION ABOUT THE POTENTIAL FOR AN ALLERGIC REACTION TO TISSUGLU. ON (B)(6) 2018, THE COMPANY RECEIVED ADDITIONAL INFORMATION FROM DR (B)(6) THAT THE PATIENT'S CONDITION HAD INCLUDED REDNESS/IRRITATION, WITH NO FEVER, NORMAL EDEMA, AND SOME MILD SWELLING. ITS WAS REPORTED THAT THE PATIENT WAS TREATED ON (B)(6) 2017 WITH KEFLEX AND MEDROL AND THE REDNESS IN THE AREA RESOLVED WITHIN A SHORT TIME. DR. (B)(6) ALLEGES THAT THE REDNESS/IRRITATION WAS PROBABLY RESOLVED BY THE MEDROL. THE SWELLING WAS TREATED BY THE PHYSICIAN AS NORMAL SEROMA WHICH IS AN EXPECTED COMPLICATION ASSOCIATED WITH ABDOMINOPLASTY SURGICAL PROCEDURES. ON (B)(6) 2018 THE PATIENT WAS REPORTED, BY DR. (B)(6), TO BE IN GOOD HEALTH AND REQUIRED NO ADDITIONAL PROCEDURES AFTER THE INITIAL ACTION ON (B)(6) 2017. THE POTENTIAL FOR ALLERGIC REACTION TO TISSUGLU® SURGICAL ADHESIVE IS STATED IN THE DIRECTIONS FOR USE FOR THE PRODUCT AS A KNOWN POTENTIAL COMPLICATION. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27976 TISSUGLU SURGICAL ADHESIVE TISSUGLU PJK COHERA MEDICAL INC TG100US CM0344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other