BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 17975226 · Received October 20, 2023

    Report

    Report Number
    2210968-2023-08068
    Event Type
    Injury
    Date Received
    October 20, 2023
    Date of Event
    September 22, 2022
    Report Date
    October 20, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6. 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? EVENT RELATED TO MW # 2210968-2023-08070. CITATION: HTTPS://DOI.ORG/10.1016/ J.JEBDP.2023.101863. 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: COMPARISON BETWEEN TWO DIFFERENT LOCAL HEMOSTATIC METHODS FOR DENTAL EXTRACTIONS IN PATIENTS ON DUAL ANTIPLATELET THERAPY: A WITHIN-PERSON, SINGLE-BLIND, RANDOMIZED STUDY. AUTHOR(S): (B)(6). CITATION: DOI: HTTPS://DOI.ORG/10.1016/ J.JEBDP.2023.101863. THIS STUDY INVESTIGATED THE EFFECTIVENESS OF THE HEMCON DENTAL DRESSING (HDD) COMPARED TO OXIDIZED CELLULOSE GAUZE. A TOTAL OF 60 PATIENTS (48 MEN, MEAN AGE 59.6 YEARS) WERE INCLUDED IN THE STUDY FROM (B)(6) 2019. EACH SURGICAL SITE WAS RANDOMIZED TO HDD OR OXIDIZED REGENERATED CELLULOSE GAUZE AS THE LOCAL HEMOSTATIC METHOD. SURGICEL (ETHICON) AND VICRYL (ETHICON) WERE UTILIZED DURING THE PROCEDURE. TH DENTAL EXTRACTIONS RANDOMIZED TO THE CONTROL GROUP RECEIVED ONE UNIT OF SURGICEL POSITIONED INSIDE ETHE POST EXTRACTION SOCKET (IN CASE OF MULTIPLE ROOTS THE HEMOSTATIC AGENT WAS CUT IN EQUAL SIZES, ONE FOR EACH ROOT CAVITY). THE REPORTED COMPLICATION INCLUDED BLEEDING (N=15) TREATMENT: GAUZE COMPRESSION AND MEDICATION. IN CONCLUSION, THE PATIENTS SUBMITTED TO DENTAL EXTRACTIONS IN USE OF DUAL ANTIPLATELET THERAPY, HDD IS SUPERIOR TO OXIDIZED CELLULOSE GAUZE REGARDING INTRA-ORAL BLEEDING TIME UP TO 20 MINUTES AFTER DENTAL EXTRACTIONS, WITH GOOD SAFETY PROFILE OVERALL FOR BOTH TECHNIQUES, SUPPORTING THE RECOMMENDATION OF NOT WITHDRAW ANTIPLATELET DRUGS BEFORE DENTAL EXTRACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962852 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention