BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADCON-L ANTI-ADHESION BARRIER GEL

    MDR report key: 342641 · Received July 12, 2001

    Report

    Report Number
    1530649-2001-00033
    Event Type
    Injury
    Date Received
    July 12, 2001
    Date of Event
    April 9, 1999
    Report Date
    July 12, 2001
    Manufacturer
    GLIATECH MEDICAL INC.
    Product Code
    MLQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MULTICENTER RETROSPECTIVE ANALYSIS OF 847 PATIENTS RECEIVING ADCON-L WAS CONDUCTED AT 10 CLINICAL CENTERS. INDIVIDUAL PT DATA WAS OBTAINED FROM THE CASE REPORT FORMS FOR PTS NOTED TO HAVE HAD AN ADVERSE EVENT. ALL PTS RECEIVING ADCON-L UNDERWENT A PRIMARY, UNI-LATERAL LUMBAR ROOT DECOMPRESSION. IN 1999, THE PT UNDERWENT A PRIMARY RIGHT L5-S1 SPINAL ROOT DECOMPRESSION. THE NEXT MONTH, THE PT PRESENTED WITH RECURRENT HERNIATED NUCLEUS PULPOSUS. THE INVESTIGATOR NOTED THE EVENT AS MODERATE IN INTENSITY. EPIDURAL STEROID INJECTION WAS ADMINISTERED. ELEVEN DAYS LATER THE PT UNDERWENT RE-OP FOR RECURRENT HNP. ALMOST 7 WEEKS LATER PT PRESENTED WITH RECURRENT HNP WHICH WAS NOTED AS SEVERE IN INTENSITY. A SECOND EPIDURAL INJECTION WAS ADMINISTERED. A SECOND RE-OP WAS PERFORMED FOUR MONTHS AFTER FIRST REOPERATION (ALIF L5-S1). BOTH EVENTS WERE CLASSIFIED AS UNRELATED TO ADCON-L AND WERE CONTRIBUTED TO AN IDIOSYNCRATIC EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31676 ADCON-L ANTI-ADHESION BARRIER GEL INHIBITOR, PERIDURAL MLQ GLIATECH MEDICAL INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization