BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXCEL GRN 4X75CM M5

    MDR report key: 10212429 · Received June 30, 2020

    Report

    Report Number
    2210968-2020-04961
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    January 1, 2020
    Report Date
    June 22, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 11/25/2020. ADDITIONAL H-6 HEALTH EFFECT - CLINICAL CODES: E171601, E0505, E2340,E1906. ADDITIONAL H-6 HEALTH EFFECT - IMPACT CODE: F19. ADDITIONAL B5 NARRATIVE: WOUND-RELATED COMPLICATIONS INCLUDED REDNESS, DEHISCENCE, SUBCUTANEOUS HEMATOMA, PROLONG WOUND DRAINAGE (> 5 DAYS), SURGICAL SITE INFECTION (SSI) AND RE-SUTURE CAUSED BY ANY REASONS. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. DATE SENT TO THE FDA: 11/25/2020.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL PLUS, ETHIBOND AND UNKNOWN ETHICON ABSORBABLE KNOTLESS BARBED RUNNING SUTURES) INVOLVED? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL PLUS, ETHIBOND AND UNKNOWN ETHICON ABSORBABLE KNOTLESS BARBED RUNNING SUTURES) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER FOR EACH PATIENT (N=34 FEMALE WITH BMI OF 27.13 KG/M2; N=31 MALE WITH BMI OF 27.65 KG/M2; AND N=37 MALE PATIENT WITH BMI OF 30.72 KG/M2)? WERE THERE ANY TREATMENTS PROVIDED FOR N=60/66 EVENTS WITH WORST IMAGINABLE SCAR? --ALL INFORMATION REQUEST ABOVE ARE UNKNOWN. CITATION: BMC MUSCULOSKELETAL DISORDERS (2020) 21:178; HTTPS://DOI.ORG/10.1186/S12891-020-03205-5 PLEASE SEE ARTICLE. EVENTS FOR 31 MALE WITH BMI OF 27.65 KG/M2 WERE SUBMITTED VIA 2210968-2020-04957, AND 2210968-2020-04962. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    TITLE: TISSUE ADHESIVE FOR WOUND CLOSURE IN ENHANCED-RECOVERY TOTAL HIP ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED AND CONTROLLED STUDY. THIS PROSPECTIVE, RANDOMIZED AND SELF-CONTROLLED STUDY AIMED TO PRESENT THE EXPERIENCE OF ADOPTING TISSUE ADHESIVE AS ADJUNCT TO STANDARD WOUND CLOSURE IN TOTAL HIP ARTHROPLASTY (THA) AND EVALUATE ITS ROLE AND COST PERFORMANCE. FROM SEPTEMBER 2019 TO NOVEMBER 2019, A TOTAL OF 30 PATIENTS (N=17 MALE, N=13 FEMALE; MEDIAN AGE: 30.5 YEARS; MEAN BMI 22.94 KG/M2) WERE ENROLLED IN THE STUDY. FOR STANDARD WOUND CLOSURE, THE FOLLOWING WERE USED FOR DIFFERENT LAYERS: 1. JOINT CAPSULE AND EXTERNAL ROTATOR MUSCLES WERE RECONSTRUCTED WITH 2¿0 ETHIBOND NON-ABSORBABLE SUTURE W4843 (ETHICON). 2. DEEP FASCIA AND SUPERFICIAL FASCIA WERE SUTURED WITH 2¿0 ABSORBABLE KNOTLESS BARBED RUNNING SUTURE AND 4¿0 COATED VICRYL PLUS ANTIBACTERIAL INTERRUPTED SUTURE (ETHICON). 3. SUBCUTICULAR TISSUE WAS CLOSED WITH 4¿0 ABSORBABLE KNOTLESS BARBED RUNNING SUTURE (ETHICON). COMPLAINT INCLUDED PROLONGED WOUND DRAINAGE IN STANDARD WOUND CLOSURE SIDE IN 3 PATIENTS (N=34 FEMALE WITH BMI OF 27.13 KG/M2; N=31 MALE WITH BMI OF 27.65 KG/M2; AND N=37 MALE PATIENT WITH BMI OF 30.72 KG/M2). TREATMENT OF THE PATIENTS INCLUDED RE-SUTURE AND ORAL ANTIBIOTICS. WOUND-RELATED EVALUATION SCORES REPORTED FOR PATIENT SCAR ASSESSMENT SCORE (PSAS) IS 30.57 (MEAN SCORE) AND N=60/66 REPRESENTS WORST IMAGINABLE SCAR; AND VANCOUVER SCAR SCORE (VSS) IS 5.77 (MEAN SCORE). IN CONCLUSION, TISSUE ADHESIVE COULD SIGNIFICANTLY REDUCE WOUND DRAINAGE AND INCREASE PATIENTS¿ SATISFACTION, WHICH CAN BE AN IDEAL ADJUNCT TO STANDARD WOUND CLOSURE IN ENHANCED RECOVERY THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677899 ETHIBOND EXCEL GRN 4X75CM M5 SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention