BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGISEAL TOPICAL SKIN ADHESIVE

    MDR report key: 4612188 · Received March 16, 2015

    Report

    Report Number
    3006385287-2015-00003
    Event Type
    Injury
    Date Received
    March 16, 2015
    Report Date
    May 10, 2017
    Manufacturer
    ADHEZION BIOMEDICAL, LLC
    Product Code
    MPN
    PMA / PMN Number
    K082993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR PROVIDED ON SINGLE REPORT WITH A BROAD DESCRIPTION OF REACTION, APPLICABLE TO MULTIPLE PTS/EVENTS. MFR DID NOT RECEIVE INDIVIDUAL PT INCIDENT INFO, THEREFORE AN ACTUAL DATE OF EVENTS IS UNK.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING COMPLETED FOR TWO REASONS. THE FIRST IS A CORRECTION TO THE INITIAL PAPER REPORT, AND THE SECOND IS TO UPDATE THE INITIAL PAPER REPORT WITH A LAB ANALYSIS AND REPORT THAT WAS CONDUCTED AFTER THE INITIAL MDR WAS FILED. THE CORRECTION TO THE INITIAL REPORT WAS FOR THE "MANUFACTURER NAME". THE ADDITIONAL INFORMATION, IS A LAB REPORT INDICATING THE PROCEDURE, DATA, AND RESULTS OF BIOCOMPATIBILITY TESTS PER ISO 10993-1.

    Description of Event or Problem · 1

    POST-OP PT EXPERIENCED A DRY RASH, EXTENDING BEYOND AREAS OF THE SURGISEAL APPLICATION. POST-OP PTS ARE EXPERIENCING A REACTION SIMILAR TO CONTACT DERMATITIS OVER THE AREA OF WHERE SURGISEAL WAS PLACED. PTS HAVE BEEN PRESCRIBED BENADRYL CREAM, ORAL BENADRYL, ORAL HYDROXYZINE AND HIGH -POTENCY TOPICAL STEROID CREAMS.

    Description of Event or Problem · 1

    AN (B)(6) INTERNATIONALLY ACCREDITED TEST LAB, WUXI APPTEC, WAS RETAINED BY THE MANUFACTURER TO CONDUCT INTRACUTANEOUS IRRITATION TESTS ON LIVE STUDY ANIMALS. THE STUDY WAS CONDUCTED IN ACCORDANCE WITH ISO 10993-10:2010 STANDARD, BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 10: TEST OF IRRITATION AND SKIN SENSITIZATION. THE TESTS WERE COMPLETED ON (B)(6) 2015. RESULTS OF THE TESTING INDICATED NONE OF THE ANIMALS SHOWED ABNORMAL CLINICAL SIGNS DURING 24, 48, AND 72 HOUR OBSERVATION PERIODS. IN ADDITION, THERE WERE NO SIGNIFICANT DERMAL REACTIONS OBSERVED AT THE INJECTED TEST AND CONTROL SITES ON THE AMINALS AT THE SAME OBSERVATION PERIODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178916 SURGISEAL TOPICAL SKIN ADHESIVE SURGISEAL "TEARDROP" MPN ADHEZION BIOMEDICAL, LLC SS035-T 134233

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other