BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 19122470 · Received April 16, 2024

    Report

    Report Number
    2210968-2024-04397
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    November 18, 2023
    Report Date
    April 16, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). COMPONENT CODE: G07002 - DEVICE NOT RETURNED 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. 1. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). 2. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? 3. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 4. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 5. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? CITATION: CHINA HOSPITAL INFECTIOUS MEDICINE JOURNAL.VOL.34 NO.10: PAGES 1-6.DOI:10.11816/CN.NI.2024-231779. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE : RISK FACTORS FOR INTRACRANIAL INFECTION AFTER TRANSCRANIAL FUNDUS AND DIRECT ECONOMIC LOSSES AUTHOR : HU AIXIANG, LI JING, YU XINWEI, CHENG SHI, HAN WEI, LI CHU ZHONG, ZHANG YUE WEI CITATION: CHINA HOSPITAL INFECTIOUS MEDICINE JOURNAL.VOL.34 NO.10: PAGES 1-6.DOI:10.11816/CN.NI.2024-231779 THE AIM OF THIS STUDY WAS TO ANALYZE THE RISK FACTORS AND DIRECT FINANCIAL LOSS FOR INTRACRANIAL INFECTION AFTER TRANSCRANIAL FUNDUS. RETROSPECTIVE SELECTION WAS MADE OF 385 PATIENTS UNDERGOING NASAL ENDOSCOPIC BASAL TUMOUR RESECTION FROM BEIJING TIANTAN HOSPITAL, CAPITAL MEDICAL UNIVERSITY JANUARY 2022 - JUNE. THERE WERE 168 MALE AND 217 FEMALE IN THIS STUDY. PRE-OPERATIVE FACTORS SUCH AS HYPERTENSION, INFORMATION SURGERY: DURATION OF SURGERY, TUMOUR DIAMETER, AMOUNT OF BLEEDING, IMPLANT (ARTIFICIAL BONE, TITANIUM NAIL/TITANIUM TABLET/TITANIUM CLIP, VENTRICULOMAL SHUNT),HEMOSTATIC MATERIAL (SWINE-BASED FIBRE EGG WHITE ADHESIVE, GELATIN SPONGE, ABSORBABLE HEMOSTATIC FLUID GELATINE , JOHNSON & JOHNSON ABSORBABLE HEMOSTATIC GAUZE, HUMAN FIBRIN ADHESIVE), DAYS OF HOSPITAL STAY, CEREBROSPINAL FLUID DRAINAGE AFTER SURGERY (LUMBAR BASIN DRAINAGE TUBE, OUTDOOR DRAINAGE TUBE), USE OF ANTIBACTERIAL DRUGS BEFORE SURGERY, AIR AND SPINAL FLUID LEAKAGE AFTER SURGERY. THE REPORTED COMPLICATION INCLUDED INTRACRANIAL INFECTIONS (N=33). IN CONCLUSION, DURING VENTRICULAR ABDOMINAL SHUNT SURGERY, IT SHOULD BE STRICTLY STERILE TO AVOID RETROGRADE BACTERIAL ENTRY INTO BRAIN TISSUE CAUSING INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868079 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other