BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 22319780 · Received June 24, 2025

    Report

    Report Number
    2210968-2025-07312
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    December 12, 2024
    Report Date
    June 24, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. H6. MEDICAL DEVICE PROBLEM CODE: E2401 - PERFORATION D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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: EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY (2025) 282:1335¿1343; HTTPS://DOI.ORG/10.1007/S00405-024-09136-4. 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: THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: OMER GL, DI GIROLAMO S, ALI SS, KAREEM RHR, ABDULLAH AS, MAURIZI R, VELLETRANI G, FRANCAVILLA B, HUSSEIN O, NOORI KH, AHMED AK, HAMAAMIN AH. ENDOSCOPIC SEPTAL PERFORATION REPAIR BY ENDONASAL FLAP: A TECHNIQUE USING MOBILIZED SEPTAL BONE OR CARTILAGE FOR SUPPORT. EUR ARCH OTORHINOLARYNGOL. 2025 MAR;282(3):1335-1343. DOI: 10.1007/S00405-024-09136-4. EPUB 2024 DEC 12. PMID: 39668223. THE AIM OF THIS STUDY IS TO INTRODUCE A NEW TECHNIQUE OF ENDOSCOPIC REPAIR OF SEPTAL PERFORATIONS, WHICH SUPPORTS THE FLAP AND IS THUS USED TO PREVENT COMMONLY ENCOUNTERED COMPLICATIONS. THIS IS A PROSPECTIVE COHORT STUDY WITH 40 PATIENTS WHO UNDERWENT THOROUGH CLINICAL EXAMINATION, INCLUDING NASAL ENDOSCOPY, TO DETERMINE THE PERFORATION DETAILS. VICRYL 4-0 (ETH) WAS USED TO SUTURE THE FLAP IN PLACE, WHILE SURGICEL (ETH) WAS USED TO PLACE ON THE SIDE WHERE THE FLAP WAS TAKEN TO MINIMIZE THE RISK OF BLEEDING. REPORTED COMPLICATIONS: VICRYL 4-0 (ETH) SURGICEL (ETH) SMALL PERFORATION (N=2) TREATMENT: MUCOPERICHONDRIAL SLIDING POST-OP BLEEDING (N=3) TREATMENT: MANAGED WITH PACKING SYNECHIA (N=1) TREATMENT: EXCISION BY BIPOLAR CAUTERY CRUSTATION (N=7) TREATMENT: CLEARANCE AND OINTMENT APPLICATION NASAL OBSTRUCTION (N=1) TREATMENT: NASAL DOUCHING IN CONCLUSION, A NEW ENDOSCOPIC TECHNIQUE THAT INVOLVES USING CARTILAGE AND BONE GRAFTS TO SUPPORT THE FLAPS USED FOR NASAL SEPTAL PERFORATION REPAIR AND REDUCE THE RISK OF ASSOCIATED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608387 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention