BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADCON-L ANTI-ADHESION BARRIER GEL

    MDR report key: 344636 · Received July 27, 2001

    Report

    Report Number
    1530649-2001-00279
    Event Type
    Injury
    Date Received
    July 27, 2001
    Report Date
    July 27, 2001
    Manufacturer
    GLIATECH MEDICAL INC.
    Product Code
    MLQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 06/2001, PRODUCT MGR REPORTED TO QUALITY ASSURANCE THAT A PRESENTATION HAD BEEN GIVEN BY AN INSTITUTE REGARDING ADCON-L AND RECURRENT DISC HERNIATIONS. THE PRESENTATION WAS GIVEN AT THE AMERICAN SPINAL INJURY ASSOCIATION MEETING. THE DATA PRESENTATION DID NOTE THAT 6 ADCON-L PTS (VERSUS 9 CONTROL PTS) HAD PRESENTED WITH RECURRENT DISC HERNIATION. PT 6 OF 6: RECURRENT DISC HERNIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33920 ADCON-L ANTI-ADHESION BARRIER GEL INHIBITOR, PERIDURAL MLQ GLIATECH MEDICAL INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA