BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTYLSEAL

    MDR report key: 3021392 · Received March 11, 2013

    Report

    Report Number
    3021392
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 2, 2013
    Report Date
    March 11, 2013
    Manufacturer
    CHEMENCE MEDICAL PRODUCTS, INC
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT RETURNED TO EMERGENCY DEPARTMENT POST-OP FROM NECK SURGERY AND BELIEVED TO BE HAVING REACTION TO ADHESIVE. PATIENT HAD SHORTNESS OF BREATH, SOME LIP SWELLING AND PAIN AT THE SURGICAL SITE ON HIS NECK.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ADHESIVE USED FOR INCISION CLOSURE. PROCEDURE: CERVICAL CORPECTOMIES FOR DECOMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102677 OCTYLSEAL TISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR