BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGISEAL TOPICAL SKIN ADHESIVE

    MDR report key: 4612187 · Received March 16, 2015

    Report

    Report Number
    3006385287-2015-00004
    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178712 SURGISEAL TOPICAL SKIN ADHESIVE SURGISEAL "TEARDROP" MPN ADHEZION BIOMEDICAL, LLC SS035-T 141031

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other