BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 8021464 · Received October 30, 2018

    Report

    Report Number
    2210968-2018-76843
    Event Type
    Injury
    Date Received
    October 30, 2018
    Report Date
    October 15, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: OTOLARYNGOL HEAD NECK SURG. 2000; 123: 218-23. DOI: 10.1067/MHN.2000.107451. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : ENDOSCOPE-ASSISTED MICROVASCULAR DECOMPRESSION OF THE TRIGEMINAL NERVE". AUTHOR: REZA JARRAHY, MD, GEORGE BERCI, MD, FACS, AND HRAYR K. SHAHINIAN, MD. CITATION: OTOLARYNGOL HEAD NECK SURG. 2000; 123: 218-23. DOI: 10.1067/MHN.2000.107451. IN A SERIES OF 21 PATIENTS WITH TRIGEMINAL NEURALGIA WHO UNDERWENT ENDOSCOPE-ASSISTED MICROVASCULAR DECOMPRESSION OF THE TRIGEMINAL NERVE, THE AUTHORS ASSESSED THE USEFULNESS OF ENDOSCOPY IN IDENTIFYING NERVE-VESSEL CONFLICTS AND IN DETERMINING THE ADEQUACY OF THERAPEUTIC PROCEDURES PERFORMED UNDER THE MICROSCOPE. DURING THE SURGICAL PROCEDURE, THE DURA IS INCISED IN A CURVILINEAR FASHION, AND NUROLON 4-0 SUTURES (ETHICON) ARE USED TO REFLECT THE SIGMOID SINUS ANTERIORLY. REPORTED POST-OPERATIVE COMPLICATIONS INCLUDED CEREBROSPINAL FLUID LEAKS (N-3) WHICH WERE REPAIRED SURGICALLY WITHOUT SUBSEQUENT COMPLICATIONS, SUPERFICIAL WOUND INFECTION (N-1) WHICH WAS SUCCESSFULLY TREATED WITH A COURSE OF ORAL ANTIBIOTICS, AND WOUND ABSCESS (N-1) WHICH REQUIRED SURGICAL DRAINAGE IN ADDITION TO A COURSE OF PARENTERAL ANTIBIOTICS. THE AUTHORS CONCLUDED THAT IN THIS SERIES, MICROSCOPIC EXPLORATION OF THE SURGICAL FIELD FAILED TO DETECT ROUGHLY ONE QUARTER OF THE OFFENDING VESSELS. LIKEWISE, IT IS EVIDENT THAT IN ONE QUARTER OF CASES, WHAT WAS DEEMED TO BE AN ADEQUATE DECOMPRESSION OF THE TRIGEMINAL NERVE UNDER THE MICROSCOPE PROVED TO BE INCOMPLETE. THESE OBSERVATIONS EMPHASIZE THE VALUE OF CONTROLLED APPLICATION OF ENDOSCOPIC TECHNIQUES AT THE CPA AND MERIT FURTHER ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862266 NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention