BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 10851361 · Received November 17, 2020

    Report

    Report Number
    2210968-2020-08421
    Event Type
    Injury
    Date Received
    November 17, 2020
    Report Date
    October 22, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS, AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: J NEUROSURGERY 128:14631472, 2018.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: 'NASOSEPTAL FLAP NECROSIS: A RARE COMPLICATION OF ENDOSCOPIC ENDONASAL SURGERY'. AUTHORS: JOSEPH D. CHABOT, DO, CHIRAG R. PATEL, MD, MARION A. HUGHES, MD, ERIC W. WANG, MD, CARL H. SNYDERMAN, MD, MBA, PAUL A. GARDNER, MD, AND JUAN C. FERNANDEZ-MIRANDA, MD CITATION: J NEUROSURG 128:14631472, 2018; DOI: 10.3171/2017.2.JNS161582. THIS RETROSPECTIVE STUDY AIMED TO DESCRIBE A SERIES OF PATIENTS WHO PRESENTED WITH THE CLINICAL SIGNS AND SYMPTOMS OF MENINGITIS AND WERE FOUND TO HAVE A NECROTIC NASOSEPTAL FLAP (NSF) ON RE-EXPLORATION. WE PRESENT THE CLINICAL PRESENTATION OF NECROTIC NSF, ITS IMAGING CHARACTERISTICS, INCIDENCE, AND RISK FACTORS. BETWEEN JANUARY 1, 2010 AND DECEMBER 31, 2014, A TOTAL OF 49 PATIENTS (N=25 MALE AND N=24 FEMALE) WERE INCLUDED IN THE FINAL ANALYSIS. THE NSF WAS HELD IN PLACE BY OXIDIZED CELLULOSE (SURGICEL) (ETHICON), FOLLOWED BY APPLICATION OF FIBRIN GLUE AND THEN FIBRIN-SOAKED GELATIN SPONGES (GELFOAM). COMPLAINT INCLUDED A NECROTIC NASOSEPTAL FLAP (N=8 [N=4 MALE, N=4 FEMALE; MEAN AGE: 54.6 YEARS; MEAN BMI: 28 KG/M2]). OF THESE PATIENTS, EMPYEMA IN THE SPACE BETWEEN THE NSF AND THE DEEPER RECONSTRUCTIVE LAYERS WAS SEEN AT THE TIME OF RE-EXPLORATION (N=4). OPERATIVE CULTURES OBTAINED FROM THE DEBRIDED FLAPS AND EMPYEMA GREW A VARIETY OF GRAM-NEGATIVE AND GRAM-POSITIVE BACTERIAL PATHOGENS, THE MOST COMMON OF WHICH WERE STREPTOCOCCUS AND PSEUDOMONAS SPECIES, EACH FOUND IN 3 PATIENTS; AND ONE PATIENT HAD DELAYED GROWTH OF CANDIDA ALBICANS. ALL PATIENTS WHO HAD NECROTIC NSF UNDERWENT AGGRESSIVE SURGICAL DEBRIDEMENT, LONG-TERM ANTIBIOTIC THERAPY, AND DEFINITIVE SKULL BASE REPAIR USING VASCULARIZED PERICRANIAL, INFERIOR TURBINATE, OR CONTRALATERAL NSF. IN CONCLUSION, THE SIGNS OF MENINGITIS AFTER EES IN THE ABSENCE OF A CLEAR CSF LEAK WITH THE LACK OF NSF ENHANCEMENT ON MRI SHOULD RAISE THE SUSPICION OF NECROTIC NSF. THESE PATIENTS SHOULD UNDERGO PROMPT EXPLORATION AND DEBRIDEMENT OF NONVIABLE TISSUE WITH REVISION OF SKULL BASE RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316774 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention