BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 17987058 · Received October 23, 2023

    Report

    Report Number
    2210968-2023-08104
    Event Type
    Injury
    Date Received
    October 23, 2023
    Date of Event
    December 23, 2022
    Report Date
    October 23, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IT WAS REPORTED VIA A JOURNAL ARTICLE: 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? CITATION: J. ORAL MAXILLOFAC. SURG. 2023; 52: 860¿868 HTTPS://DOI.ORG/10.1016/J.IJOM.2022.11.016 EVENT RELATED TO MW # 2210968-2023-08106, MW # 2210968-2023-08107. 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: INFLUENCE OF A RESORBABLE COLLAGEN MEMBRANE FOR ALVEOLAR BONE GRAFT ON CLINICAL OUTCOMES AND RIDGE VOLUME STABILITY IN CLEFT ALVEOLUS AUTHORS: T. SINGKHORN, P. PRIPATNANONT, T. NUNTANARANONT, D. SUPAKANJANAKANTI, W. RITTHAGOL CITATION: INT. J. ORAL MAXILLOFAC. SURG. 2023; 52: 860¿868. HTTPS://DOI.ORG/10.1016/J.IJOM.2022.11.016 THE OBJECTIVE OF THIS STUDY IS TO COMPARE THE CLINICAL OUTCOMES, GRAFT QUALITY, AND GRAFT QUANTITY AFTER ALVEOLAR BONE GRAFTING WITH AND WITHOUT A RESORBABLE COLLAGEN MEMBRANE. A TOTAL OF 22 PATIENTS AGED BETWEEN 8 AND 21 YEARS. 12 FEMALES AND 8 MALES. TWO PATIENTS, ONE FROM EACH GROUP, WERE LOST TO FOLLOW-UP DUE TO THE COVID-19 PANDEMIC. TWENTY PATIENTS (10 IN EACH GROUP) WERE FOLLOWED UP FOR AT LEAST 6 MONTHS POSTOPERATIVELY. THERE WAS NO CASE OF INFECTION AFTER THE OPERATION, BUT WOUND DEHISCENCE WAS OBSERVED IN TWO CASES, ONE IN EACH GROUP. THE MB/MEMBRANE GROUP PATIENTS REPORTED SIGNIFICANTLY LESS POSTOPERATIVE PAIN THAN THE ST/STANDARD GROUP PATIENTS. THE MB GROUP SHOWED A TENDENCY FOR LESS SWELLING THAN THE ST GROUP. SURGICEL (ETHICON, SOMERVILLE, NJ, USA) WAS USED FOR HEMOSTASIS. THE PEDICLE WAS CLOSED WITH 2¿0 VICRYL SUTURES AND THE WOUND WAS CLOSED LAYER BY LAYER USING DEEP DERMAL 4¿0 VICRYL (ETHICON, RARITAN, NJ, USA), SUBCUTICULAR 4¿0 MONOCRYL (ETHICON), AND STERI-STRIPS (3 M, SAINT PAUL, MN, USA) REPORTED COMPLICATIONS INCLUDED WOUND DEHISCENCE (N=2), POSTOPERATIVE PAIN (N=?), FACIAL SWELLING (N=?). IN CONCLUSION, THE COLLAGEN MEMBRANE FACILITATED PREDICTABLE CLINICAL OUTCOMES IN BONE MATURATION, BONE VOLUME PRESERVATION, AND BONE BRIDGING IN THE ALVEOLAR BONE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143104 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention