BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22202666 · Received June 13, 2025

    Report

    Report Number
    2210968-2025-06833
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    April 9, 2025
    Report Date
    June 13, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. H6. HEALTH EFFECT - CLINICAL CODE: E2401 - IRD 2 CM BELOW UMBILICUS >21 MM. 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: 2025 JUN;310:113966. DOI: 10.1016/J.EJOGRB.2025.113966. EPUB 2025 APR 9. PMID: 40209487. 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: ASLAN CETIN B, TOPBAS F, KESKIN TOPTAS K, KONAL M, SENOL G. RECTUS MUSCLE REAPPROXIMATION AT CESAREAN DELIVERY: A RANDOMIZED CONTROLLED TRIAL. EUR J OBSTET GYNECOL REPROD BIOL. 2025 JUN; 310:113966. DOI: 10.1016/J.EJOGRB.2025.113966. EPUB 2025 APR 9. PMID: 40209487. THIS PROSPECTIVE, RANDOMIZED STUDY AIMED TO INVESTIGATE THE EFFECT OF RECTUS MUSCLE REAPPROXIMATION AT CESAREAN DELIVERY (CD) ON POSTOPERATIVE PAIN AND RECTUS MUSCLE DIASTASIS. BETWEEN DECEMBER 2019 AND MARCH 2021, A TOTAL OF 306 WOMEN WERE INCLUDED IN THE STUDY AND EACH GROUP INCLUDED 153 PATIENTS. 10 WOMEN DID NOT COME TO CONTROL 6 WEEKS AFTER CD (CESAREAN DELIVERY) AND WERE EXCLUDED FROM FINAL ANALYSIS. 296 WOMEN WERE INCLUDED INTO THE FINAL ANALYSIS. THE RECTUS MUSCLE REAPPROXIMATION GROUP HAD 147 PATIENTS, AND THE CONTROL GROUP HAD 149 PATIENTS. THESE PATIENTS UNDERWENT PRIMARY CESAREAN SECTION WITH 2-0 POLYGLACTIN 910 (VICRYL, ETHICON). REPORTED COMPLICATIONS ARE. N=9; IRD 2 CM BELOW UMBILICUS >21 MM. N=?; POST-OPERATIVE VAS SCORE. IN CONCLUSION, RECTUS MUSCLE REAPPROXIMATION DURING CD RESULTED IN LESS RECTUS DIASTASIS BELOW UMBILICUS. ON THE OTHER HAND IT, DID NOT AFFECT POSTOPERATIVE VAS SCORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636609 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention