BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADCON-L ANTI-ADHESION BARRIER GEL

    MDR report key: 350525 · Received September 7, 2001

    Report

    Report Number
    1530649-2001-00299
    Event Type
    Injury
    Date Received
    September 7, 2001
    Date of Event
    August 8, 2001
    Report Date
    September 7, 2001
    Manufacturer
    GLIATECH MEDICAL INC.
    Product Code
    MLQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2001 THE PATIENT UNDERWENT AN L5-S1 DISCECTOMY DURING WHICH 2G OF ADCON-L WAS APPLIED. ABOUT 3-4 MINUTES AFTER APPLICATION OF ADCON-L THE EVENT OCCURRED WHICH WAS HYPOTENSION AND TACHYCARDIA. SYMPTOMS EXPERIENCED WERE "BP DROPPED FROM 100 MM HG SYSTOLIC TO 60 MM HG. HR INCREASED BY 10-20 BEATS/MIN. NO "ST" DEPRESSION. THE PATIENT "DID NOT NEED ADRENALINE" BUT "USED EPHEDRINE 10-20 MG AND CRYSTALLOID/COLLOID." THE LENGTH OF ONSET AND THE RESOLUTION OF THE EVENT WAS REPORTED TO BE 30 MINUTES. SENSITIVITY TESTING IS LIKELY TO BE PERFORMED AND BLOOD SAMPLES FOR MAST CELL HISTOLOGY HAVE BEEN COLLECTED AND WILL TAKE ABOUT 6 WEEKS TO COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40591 ADCON-L ANTI-ADHESION BARRIER GEL INHIBITOR, PERIDUAL MLQ GLIATECH MEDICAL INC. NA A01099N1

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention