BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 8114006 · Received November 28, 2018

    Report

    Report Number
    2210968-2018-77393
    Event Type
    Injury
    Date Received
    November 28, 2018
    Report Date
    November 2, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    LMF
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO FDA: 11/29/2018. ADDITIONAL INFORMATION: ARTICLE LOCATED: HTTP://DX.DOI.ORG/10.21037/QIMS.2018.09.04. TITLE: HAEMOSTATIC MATERIAL (SURGICEL®) MIMICKING RESIDUAL TUMOUR: MAGNETIC RESONANCE IMAGING FINDINGS IN OPERATED PEDIATRIC NEURO-ONCOLOGY CASES. AUTHOR: SERENA STAGLIANÒ, FELICE D¿ARCO, AI PENG TAN, OWASE JEELANI, GIOVANNI MORANA, KSHITIJ MANKAD. CITATION: QUANT IMAGING MED SURG. 2018; 8(9): 971-978. DOI: 10.21037/QIMS.2018.09.04.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # : (B)(4). CORRECTED INFORMATION: ADDITIONAL INFORMATION RECEIVED INDICATES THAT THIS EVENT DOES NOT MEET REPORTING SERIOUS INJURY CRITERIA. THIS EVENT THEREFORE IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOCTOR / AUTHOR REPORTS: I WOULD LIKE TO HIGHLIGHT THAT THIS PAPER WAS TO HIGHLIGHT A RADIOLOGICAL INTERPRETATION PROBLEM, NOTHING TO DO WITH YOUR PRODUCT AND DOES NOT BELIEVE THERE IS ANY PRODUCT DEFICIENCY.

    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. 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 A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? REFERENCE: HAEMOSTATIC MATERIAL (SURGICEL®) MIMICKING RESIDUAL TUMOUR: MAGNETIC RESONANCE IMAGING FINDINGS IN OPERATED PEDIATRIC NEURO-ONCOLOGY CASES AUTHOR : SERENA STAGLIANÒ, FELICE D¿ARCO, AI PENG TAN, OWASE JEELANI, GIOVANNI MORANA, KSHITIJ MANKAD CITATION: QUANT IMAGING MED SURG. 2018; 8(9): 971-978. DOI: 10.21037/QIMS.2018.09.04.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: HAEMOSTATIC MATERIAL (SURGICEL®) MIMICKING RESIDUAL TUMOUR: MAGNETIC RESONANCE IMAGING FINDINGS IN OPERATED PEDIATRIC NEURO-ONCOLOGY CASES. THE AIM OF THIS PAPER WAS TO REPORT THREE NEURO-ONCOLOGIC PEDIATRIC CASES WHERE THE PRESENCE OF SURGICEL (ETHICON) IN THE SURGICAL BED CAUSED A DIAGNOSTIC CHALLENGE AND WAS INITIALLY MISDIAGNOSED AS TUMOR RESIDUUM/RECURRENCE. CASE 3, A (B)(6) MALE WITH MENINGEAL FIBROSARCOMA. THE PATIENT UNDERWENT SURGICAL REMOVAL AND SURGICEL (ETHICON) HEMOSTATIC AGENT WAS USED DURING THE PROCEDURE. FOLLOW-UP MRI SHOWED EVIDENCE OF AMORPHOUS TISSUE WITH RESTRICTED DIFFUSION SUGGESTIVE OF FOREIGN BODY INFLAMMATORY REACTION TO THE HEMOSTATIC MATERIAL. SURGICEL (ETHICON)-ASSOCIATED CLOT FORMATION AND GRANULOMATOUS REACTION RESULT IN VARIABLE IMAGING APPEARANCES ON FOLLOW UP MRI, INCLUDING FOCAL AREAS OF ENHANCEMENT AND RESTRICTED DIFFUSION, BOTH OF WHICH MAY SIMULATE RESIDUAL DISEASE. AWARENESS OF THIS PHENOMENON IS CRUCIAL AS THE DETERMINATION OF THE PRESENCE OF RESIDUAL DISEASE GREATLY IMPACTS MANAGEMENT PLAN AND PROGNOSTICATION. THE AUTHORS RECOMMENDED THE INCLUSION AND CAREFUL EVALUATION OF DIFFUSION-WEIGHTED SEQUENCE IN ALL POST-OPERATIVE IMAGING PROTOCOLS, ESPECIALLY IF THE PRIMARY TUMOUR SHOWS NO EVIDENCE OF RESTRICTED DIFFUSION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949394 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN HEMOSTATIC AGENT, ABSORBABLE LMF ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention