BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIQUIBAND EXCEED

    MDR report key: 11758733 · Received May 2, 2021

    Report

    Report Number
    9617175-2021-00021
    Event Type
    Injury
    Date Received
    May 2, 2021
    Date of Event
    January 1, 2021
    Report Date
    May 2, 2021
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LTD
    Product Code
    MPN
    PMA / PMN Number
    K151182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    ACCORDING TO THE REPORTER, POST-OPERATIVE AN IMPLANT EXCHANGE, IT WAS REPORTED THE PATIENT HAD DERMATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655034 LIQUIBAND EXCEED TOPICAL SKIN ADHESIVE MPN ADVANCED MEDICAL SOLUTIONS LTD 72014008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other