BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIQUIBAND EXCEED

    MDR report key: 14111434 · Received April 14, 2022

    Report

    Report Number
    9617175-2022-00015
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    January 2, 2022
    Report Date
    April 14, 2022
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LTD
    Product Code
    MPN
    UDI-DI
    10884521543430
    PMA / PMN Number
    K151182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN IF DEVICE CAUSED OR CONTRIBUTED TO 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 · 0

    OCCURRENCE OF REDNESS 2 TO 3 WEEK AFTER THE GLUE APPLICATION, AFTER MAMMARY SURGERY. NO FURTHER DETAILS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146698 LIQUIBAND EXCEED TOPICAL SKIN ADHESIVE MPN ADVANCED MEDICAL SOLUTIONS LTD 72014002 10884521543430

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other