BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DS3 SPINE 5ML US

    MDR report key: 3911584 · Received June 27, 2014

    Report

    Report Number
    1219930-2014-00487
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SPINE. ON (B)(6) 2014, CLINICAL AFFAIRS BECAME AWARE OF A SERIOUS ADVERSE EVENT ASSOCIATED WITH ONE OF COVIDIENS PRODUCT LINES AS PART OF THE (B)(6) POST-APPROVAL STUDY. TWO BOXES WERE OPENED AND THE SITE WAS UNABLE TO DETERMINE WHICH WAS USED. SUBJECT NUMBER: (B)(6). ONSET DATE: (B)(6)-2014. RESOLVED: CONTINUING. SEVERITY: MILD. RELATIONSHIP TO DEVICE: DEFINITE. OUTCOME: CONTINUING. SUMMARY OF EVENTS: SUBJECT (B)(6) IS AN (B)(6) CAUCASIAN MALE WITH A PAST MEDICAL HISTORY OF LOW BACK PAIN AND DEGENERATIVE DISK DISEASE. THE SUBJECT HAD PREVIOUS SURGERY AT C3/4 AND HAD A LOOSE SPINOUS PROCESS REMOVED AT T2. ON (B)(6) 2014, THE SUBJECT WAS ADMITTED TO (B)(6), WHERE DR. (B)(6) PERFORMED A FORAMINOTOMY AND DECOMPRESSIVE PROCEDURE AT L2-S1 TO TREAT SPINAL STENOSIS. DURING THE PROCEDURE: AN INCIDENTAL DURAL TEAR OCCURRED, WHICH WAS CLOSED WITH SUTURES. THE LENGTH OF THE INCISION IS UNK. DURAGEN WAS PLACED OVER TH TEAR, AND THE AREA WAS THEN SEALED WITH DURASEAL (AMOUNT UNK). ONCE A WATERTIGHT CLOSURE WAS OBTAINED, THE WOUND WAS THEN CLOSED WITH SUTURES. A BLACK DRAIN WAS PLACED. ON (B)(6) 2014 (POST-OP DAT (B)(6)), SWELLING AND TENDERNESS AT THE SURGICAL SITE WAS NOTED. THE EVENT WAS DIAGNOSED AS A CSF LEAK AND TREATED WITH A BLOOD PATCH. THE EVENT IS CURRENTLY ONGOING. THE PT CATEGORIZED THIS EVENT WAS DEFINITELY RELATED TO DURASEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376266 DS3 SPINE 5ML US DURASEAL NQR COVIDIEN, FORMERLY US SURGICAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other