BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADCON-L

    MDR report key: 269171 · Received March 13, 2000

    Report

    Report Number
    1530649-2000-00046
    Event Type
    Injury
    Date Received
    March 13, 2000
    Report Date
    March 7, 2000
    Manufacturer
    GLIATECH INC.
    Product Code
    MLQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A SPINAL SURGICAL PROCEDURE IN WHICH ADCON GEL WAS ADMINISTERED. WITHIN 6 WEEKS POST-OPERATIVELY, THE PT PRESENTED WITH PSEUDOMENINGOCELE.

    Description of Event or Problem · 1

    THIS PT UNDERWENT A RE-OPERATION FOR TREATMENT OF A L4-L5 LEFT HNP (LIMITED DISCECTOMY) IN WHICH ADCON GEL WAS ADMINISTERED. AN INTRAOPERATIVE DURAL TEAR WAS RECOGNIZED AND REPAIRED DURING SURGERY. THE PT SUFFERED HEADACHES STARTING ON THE DAY OF SURGERY. A MRI WAS CONDUCTED AND THE PT WAS DIAGNOSED WITH PSEUDOMENINGOCLE. THE PT UNDERWENT A RE-OPERATION (I.E., OPEN EXPLORATION) AND WAS TREATED WITH AN EPIDURAL BLOOD PATCH. THE PT RECOVERED WITH NO SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADCON-L ANTI-ADHESION BARRIER GEL MLQ GLIATECH INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other