BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADCON-L ANTI-ADHESION BARRIER GEL

    MDR report key: 342646 · Received July 12, 2001

    Report

    Report Number
    1530649-2001-00048
    Event Type
    Injury
    Date Received
    July 12, 2001
    Date of Event
    September 1, 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 1998, THE PT UNDERWENT A PRIMARY LEFT L5-S1 SPINAL ROOT DECOMPRESSION. THE NEXT MONTH, THE PT PRESENTED WITH RECURRENT LEFT L5-S1 HERNIATED NUCLEUS PULPOSUS (HNP) WHICH WAS SEVERE IN INTENSITY. THE PT UNDERWENT A REVISION LEFT L5-S1 MICRODISCECTOMY 2 MONTHS LATER AND SYMPTOMS RESOLVED WITH THE TREATMENT (SURGERY). IN 2000, THE PT PRESENTED AGAIN WITH RECURRENT LEFT L5-S1 HNP AND UNDERWENT A SECOND REVISION LEFT L5-S1 MICRODISCECTOMY THAT SAME MONTH WHICH RESOLVED WITH TREATMENT (SURGERY). THE EVENTS WERE CLASSIFIED AS UNRELATED TO ADCON-L AND WERE CONSIDERED IDIOSYNCRATIC EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31557 ADCON-L ANTI-ADHESION BARRIER GEL INHIBITOR, PERIDURAL MLQ GLIATECH MEDICAL INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization