BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIQUIBAND EXCEED

    MDR report key: 11602480 · Received April 1, 2021

    Report

    Report Number
    9617175-2021-00009
    Event Type
    Injury
    Date Received
    April 1, 2021
    Report Date
    May 9, 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

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, POST-OPERATIVELY OF A LAPAROSCOPIC GASTRIC BYPASS WHERE THE INCISION SITES WERE CLOSED WITH THE SKIN GLUE, THE PATIENT HAD A NEGATIVE REACTION TO THE DEVICE WHICH LEAD TO DERMATITIS. PETROLEUM JELLY WAS USED TO REMOVE ANY REMAINING GLUE TO TREAT THE DERMATITIS.

    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 LAST 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500439 LIQUIBAND EXCEED TOPICAL SKIN ADHESIVE MPN ADVANCED MEDICAL SOLUTIONS LTD 72014008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other