BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 21784574 · Received April 7, 2025

    Report

    Report Number
    2210968-2025-03630
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    September 1, 2024
    Report Date
    April 7, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (B)(4) GTIN IS NOT AVAILABLE. CITATION: AM J OBSTET GYNECOL MFM. 2024 SEP;6(9):101431. HTTPS//DOI.ORG/10.1016/J.AJOGMF.2024.101431. EPUB 2024 JUL 16. PMID: 39019212.

    Description of Event or Problem · 0

    TITLE: BARBED VS CONVENTIONAL SUTURES FOR CESAREAN UTERINE SCAR DEFECTS: A RANDOMIZED CLINICAL TRIAL. THIS MULTICENTER, PARALLEL-GROUP, RANDOMIZED, CONTROLLED CLINICAL TRIAL COMPARED CLINICAL AND ULTRASONOGRAPHIC OUTCOMES OF UTERINE SCAR DEFECTS AFTER C-SECTION WITH BARBED AND CONVENTIONAL SMOOTH THREAD SUTURES. BETWEEN MAY 2020 AND MARCH 2023, 220 PARTICIPANTS WHO UNDERWENT C-SECTION USING 1-0 POLYGLACTIN VICRYL CONTROLLED RELEASE (ETH), WERE DIVIDED INTO TWO EQUAL GROUPS AND RECEIVED EITHER CONTINUOUS ABSORPTION THREADS USING 0-VICRYL (ETH) FOR THE CONVENTIONAL GROUP (N=110) OR BARBED THREADS USING 0-STRATAFIX SPIRAL PDS PLUS (ETH) FOR THE BARBED GROUP (N=110). REPORTED COMPLICATIONS ARE VICRYL (1-0 AND 0; ETHICON), SUSPECTED INFECTION (N=5), TREATMENT NOT REPORTED. INTRAUTERINE HEMATOMA (N=21) TREATMENT NOT REPORTED. EXTRAUTERINE HEMATOMA (N=4) TREATMENT NOT REPORTED. ABNORMAL BLEEDING (N=5) TREATMENT NOT REPORTED. UTERINE NICHES (N=107) TREATMENT: NOT REPORTED. IN CONCLUSION, BARBED SUTURES APPEAR TO EFFECTIVELY REDUCE C-SECTION SCAR NICHES. BARBED SUTURES OFFER CLOSE ADHERENCE TO THE MUSCLE LAYER AND EXHIBIT SUPERIOR HEMOSTATIC CAPABILITIES. THEIR DESIGN ENSURES WOUND CLOSURE WITHOUT UNDUE TENSION AND AVOIDS SUTURE FAILURES STEMMING FROM ABSENT KNOTS THUS MAKING THEM SUITABLE FOR ORGANS WITH EXPANSIVE TENDENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847554 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other