BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIQUIBAND EXCEED

    MDR report key: 11603418 · Received April 1, 2021

    Report

    Report Number
    9617175-2021-00013
    Event Type
    Injury
    Date Received
    April 1, 2021
    Report Date
    April 1, 2021
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LTD
    Product Code
    MPN
    PMA / PMN Number
    K151182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE CANNOT CONFIRM OR DENY THAT LIQUIBAND EXCEED CAUSED A SERIOUS INJURY. THERE IS A SMALL PERCENTAGE OF THE POPULATION WITH A NATURAL SENSITIVITY TO CYANOACRYLATE ADHESIVE. THIS IS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 1

    SKIN REACTIONS USUALLY NOTICED 2 TO 3 WEEKS AFTER SURGERY. 11 COMPLAINTS OVER THE LAST 11 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500722 LIQUIBAND EXCEED TOPCAIL SKIN ADHESIVE MPN ADVANCED MEDICAL SOLUTIONS LTD 72014008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other