BEUDAMED
    FDA Adverse Event Summary report: N

    SURGISEAL TOPICAL SKIN ADHESIVE

    MDR report key: 6291711 · Received January 31, 2017

    Report

    Report Number
    3006385287-2017-00001
    Date Received
    January 31, 2017
    Date of Event
    July 20, 2016
    Report Date
    July 21, 2016
    Manufacturer
    ADHEZION BIOMEDICAL, LLC
    Product Code
    MPN
    UDI-DI
    M495SS050S1
    PMA / PMN Number
    K130474
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR BEING FILED 1/2017 AS A RESULT OF MANAGEMENT CHANGE AND A REVIEW OF COMPLAINTS PREVIOUSLY DETERMINED TO BE NON-REPORTABLE, NOW DETERMINED TO BE REPORTABLE. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    "A SALES REPRESENTATIVE MENTIONED THAT A MATERIAL MANAGER REPORTED, THAT A PATIENT HAD AN INFECTION AND THE WOUND OPENED UP ON USING SURGISEAL STYLUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72634 SURGISEAL TOPICAL SKIN ADHESIVE TOPICAL SKIN ADHESIVE MPN ADHEZION BIOMEDICAL, LLC SS-050S M495SS050S1

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other