BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 10853016 · Received November 17, 2020

    Report

    Report Number
    2210968-2020-09087
    Event Type
    Injury
    Date Received
    November 17, 2020
    Report Date
    October 27, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. "WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE COMPLAINT REFERENCE NUMBERS. "DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT SURGICEL ABSORBABLE HEMOSTAT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENT DESCRIBED IN THE ARTICLE? IF YES, PLEASE PROVIDE EVENT DETAILS INCLUDING: INITIAL PROCEDURE DATE. - PROCEDURE NAME. SPECIFIC PATIENT DEMOGRAPHICS. WHERE WAS THE PROCEDURE PERFORMED? EVENT DATE. WAS MEDICAL/SURGICAL INTERVENTION PERFORMED? SURGICEL PRODUCT INVOLVED; PRODUCT CODE AND LOT NUMBER. - PATIENT PRE-EXISTING CONDITIONS/OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS. - ARE ANY DEVICES AVAILABLE FOR EVALUATION? IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: THE JOURNAL OF BIOMEDICAL RESEARCH, 2020 34(2): 143-148.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE, TITLE: 'ANGIOSARCOMATOUS COMPONENT IN GLIOSARCOMA: CASE REPORT AND CONSIDERATION OF DIAGNOSTIC CHALLENGE AND HEMORRHAGIC PROPENSITY'. AUTHORS: NANCY JIANG, RAMIRO LARRAZABAL, WALEED ALSUNBUL, AND JIAN-QIANG LU; CITATION: THE JOURNAL OF BIOMEDICAL RESEARCH, 2020 34(2): 143148; HTTPS://DOI.ORG/10.7555/JBR.33.20190080. THE AIM OF THIS CASE REPORT IS TO DESCRIBE A UNIQUE CASE OF GLIOSARCOMA WITH AN ANGIOSARCOMATOUS COMPONENT IN WHICH SURGICAL RESECTIONS REQUIRED GREATER EFFORTS TO CONTROL INTRAOPERATIVE BLEEDING AND TO MAINTAIN HEMOSTASIS. A 61-YEAR-OLD MALE PATIENT WAS PRESENTED WITH FOUR WEEKS OF PERIPHERAL VISION LOSS AND DIFFICULTY WALKING. PHYSICAL EXAMINATION REVEALED LEFT HOMONYMOUS HEMIANOPSIA AND HESITANT GAIT LIKELY DUE TO HIS VISION DEFICIT. THE BRAIN MAGNETIC RESONANCE IMAGING (MRI) SHOWED A PERIPHERALLY LOCATED, WELL DEMARCATED AND THICK-WALLED LESION IN THE RIGHT OCCIPITAL LOBE WITH MULTIPLE FLOW VOIDS NOTED. ON POST-CONTRAST T1-WEIGHTED IMAGES, THE LESION DEMONSTRATED NOT ONLY RIM-LIKE ENHANCEMENT BUT ALSO INTRATUMORAL STRIP (PALIFORM) AND NODULAR ENHANCEMENT. ON DIFFUSION-WEIGHTED IMAGES, THE PALIFORM AND NODULAR COMPONENTS EXHIBITED AREAS WITH RESTRICTED DIFFUSION. THE LESION APPEARED TO BE INSEPARABLE FROM THE RIGHT TENTORIAL LEAFLET. THERE WAS SIGNIFICANT MASS EFFECT INCLUDING A 3 MM LEFTWARD MIDLINE SHIFT, PARTIAL EFFACEMENT OF RIGHT OCCIPITAL HORN AND MODERATE PERILESIONAL EDEMA. THE PATIENT SUBSEQUENTLY UNDERWENT A RIGHT OCCIPITAL CRANIOTOMY FOR RESECTION OF THE MASS. THERE WAS CONSIDERABLE BLOOD OOZING FROM THE MASS, WHICH REQUIRED EXTENSIVE IRRIGATION AND USING MULTIPLE SURGICELS (ETHICON) AND FLOSEALS. THE PATIENT EXPERIENCED A 1.5 L BLOOD LOSS DURING THE RESECTION AND THE NEUROSURGICAL TEAM ELECTED TO STOP AFTER PARTIAL RESECTION OF THE MASS. THE POSTOPERATIVE MRI EXHIBITED THE RESIDUAL TUMOR AND SURGICAL CAVITY WITH FOCAL HEMORRHAGE (DESPITE GREATER EFFORTS TO CONTROL BLEEDING DURING THE OPERATION) AND FLUID COLLECTION. IN CONCLUSION, AWARENESS OF PERPLEXING RADIOGRAPHICALLY HETEROGENEITY OF GLIOSARCOMA AND THE INCREASED HEMORRHAGE RISK OF AN ANGIOSARCOMATOUS COMPONENT IN GLIOSARCOMA IS IMPORTANT FOR THE PATIENT'S PREOPERATIVE DIAGNOSIS, AND SURGICAL MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317813 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention