BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 23302610 · Received October 15, 2025

    Report

    Report Number
    2210968-2025-11890
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    April 12, 2025
    Report Date
    October 15, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) 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: DOI: 10.1186/S12903-025-05949-9. PMID: 40221663; PMCID: PMC11993950. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JOHANSSON K, BECKTOR JP, NAIMI-AKBAR A, SVENSSON PJ, GÖTRICK B. CONTINUOUS USE OF DIRECT ORAL ANTICOAGULANTS DURING AND AFTER SIMPLE AND SURGICAL TOOTH EXTRACTIONS: A PROSPECTIVE CLINICAL COHORT STUDY. BMC ORAL HEALTH. 2025 APR 12;25(1):554. DOI: 10.1186/S12903-025-05949-9. PMID: 40221663; PMCID: PMC11993950. THE AIM OF THIS STUDY IS TO ASSESSED THE RISK OF BLEEDING AND OTHER COMPLICATIONS IN PATIENTS WHO CONTINUE TO USE DOACS DURING AND AFTER SIMPLE AND SURGICAL TOOTH EXTRACTIONS. BETWEEN Y 2016 AND DECEMBER 2023, A TOTAL OF 210 PATIENTS WHO CONSTITUTED THE FINAL STUDY POPULATION. OF THE PATIENTS, 154 RECEIVED A DOAC AND 56, WARFARIN. THE PARTICIPANTS WERE FEMALE (DOAC : 75(49); WARFARIN : 19(34) ), AND HAD AN AVERAGE AGE OF 65 TO 80 YEARS. A LOCAL RESORBABLE HAEMOSTATIC AGENT (SURGICEL¿ , ETHICON US, LLC, SPONGOSTAN¿ DENTAL, ETHICON US, LLC OR LYOSTYPT®, B. BRAUN SURGICAL) WAS FREQUENTLY PLACED IN THE SOCKET. REPORTED COMPLICATIONS ARE : LOCAL RESORBABLE HAEMOSTATIC AGENT (SURGICEL¿ , ETHICON) POSTOPERATIVE BLEEDING: WARFARIN (N=17); DOAC (N=33) TREATMENT : NOT PROVIDED. -GRADE 2 BLEEDING : WARFARIN (N=6); DOAC (N=5) TREATMENT : NOT PROVIDED. -OTHER COMPLICATIONS : DOAC (N=8) TREATMENT : NOT PROVIDED. LOCAL RESORBABLE HAEMOSTATIC AGENT (SURGICEL¿ , ETHICON) 75-YEAR-OLD FEMALE SHE DEVELOPED BLEEDING WITH AN INR OF 6.8 (N=1) TREATMENT: THE BLEEDING WAS CONTROLLED WITH COMPRESSION, WARFARIN WAS DISCONTINUED, AND SHE RECEIVED VITAMIN K. LOCAL RESORBABLE HAEMOSTATIC AGENT (SURGICEL¿ , ETHICON) 73-YEAR-OLD MALE LOCAL INFECTION (N=1) TREATMENT : SYSTEMIC ANTIBIOTICS WERE PRESCRIBED, AND WARFARIN WAS DISCONTINUED. ADDITIONAL SUTURING AND DEBRIDEMENT WERE PERFORMED SEVEN DAYS POSTOPERATIVELY. BLEEDING (N=1) TREATMENT : SYSTEMIC ANTIBIOTICS WERE PRESCRIBED, AND WARFARIN WAS DISCONTINUED. ADDITIONAL SUTURING AND DEBRIDEMENT WERE PERFORMED SEVEN DAYS POSTOPERATIVELY. IN CONCLUSION, THE FINDINGS OF THIS STUDY INDICATE THAT PATIENTS TAKING DOACS WITHOUT INTERRUPTION MAY HAVE A LOWER RISK OF BLEEDING COMPARED TO THOSE ON THERAPEUTIC LEVELS OF WARFARIN DURING SIMPLE AND SURGICAL TOOTH REMOVAL. TO LOWER THE RISK OF THROMBOEMBOLIC EVENTS ASSOCIATED WITH THE CESSATION OF ANTICOAGULANTS, IT IS SUGGESTED THAT PATIENTS CONTINUE THEIR DOACS WITHOUT INTERRUPTION THROUGHOUT BOTH ROUTINE AND SURGICAL TOOTH EXTRACTIONS, PROVIDED THAT LOCAL HAEMOSTATIC MEASURES ARE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020495 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention