BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIQUIBAND SURGICAL S

    MDR report key: 11783714 · Received May 6, 2021

    Report

    Report Number
    9617175-2021-00022
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    March 27, 2021
    Report Date
    June 24, 2021
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LTD
    Product Code
    MPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE CANNOT CONFIRM OR DENY THAT LIQUIBAND SURGICAL S 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 · 0

    ALLERGIC SKIN REACTION (ITCHING, REDNESS AND PAPULES) OCCURRED 3 DAYS AFTER SURGERY ON HERNIATED DISC, AROUND THE SCAR, IN A WOMAN WITH A HISTORY OF ALLERGY (MEDICINAL PRODUCT). FOLLOW-UP INFORMATION RECEIVED: AT THE FOLLOW-UP VISIT, THE WOUND WAS WELL CLOSED BUT SOME RESIDUAL BLISTER MARKS WERE NOTICED. ACCORDING TO THE NEUROSURGEON, THE OUTCOME WAS RESOLVED WITH LOCAL CORTICOSTEROIDS AND ORAL ANTIHISTAMINES IN 15 DAYS.

    Additional Manufacturer Narrative · 1

    WE CANNOT CONFIRM OR DENY THAT LIQUIBAND SURGICAL S 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

    ALLERGIC SKIN REACTION (ITCHING, REDNESS AND PAPULES) OCCURRED 3 DAYS AFTER SURGERY ON A HERNIATED DISC, AROUND THE SCAR. PATIENT TREATED WITH ORAL ANTIHISTAMINICS + LOCAL CORTICOSTEROID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682130 LIQUIBAND SURGICAL S TOPICAL SKIN ADHESIVE MPN ADVANCED MEDICAL SOLUTIONS LTD LBS-S 0001

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other