BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24365451 · Received February 17, 2026

    Report

    Report Number
    2210968-2026-01679
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    November 15, 2016
    Report Date
    February 17, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. 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 (01) GTIN IS NOT AVAILABLE. CITATION: OBSTET GYNECOL SCI. 2016 NOV;59(6):525-529. HTTPS://DOI.ORG/10.5468/OGS.2016.59.6.525 EPUB 2016 NOV 15. PMID: 27896256; PMCID: PMC5120073.

    Description of Event or Problem · 0

    TITLE: COMPARATIVE ANALYSIS OF OUTCOME BETWEEN LAPAROSCOPIC VERSUS OPEN SURGICAL REPAIR FOR VESICO-VAGINAL FISTULA. THE AIM OF THIS STUDY IS TO REPORT THE EXPERIENCE IN THE REPAIR OF VESICOVAGINAL FISTULAS (VVF) BY OPEN AND LAPAROSCOPIC TECHNIQUES AND COMPARE OUTCOMES IN 67 PATIENTS FROM 2017 TO 2022. 27 WERE MANAGED LAPAROSCOPICALLY (GROUP 1) AND 33 BY OPEN REPAIR (GROUP 2). VICRYL (0,2-0;ETH) WERE USED TO REPAIR THE VAGINAL WALL AND OPENING, BLADDER, AND WAS USED TO CLOSED THE CYSTOTOMY AND THE PORT SITE. REPORTED COMPLICATIONS: VICRYL (ETH). LAPAROSCOPIC REPAIR GROUP 1 (N=27). ABDOMINAL DISTENTION (N=2). TREATMENT: MANAGED CONSERVATIVELY. UTI (N=3). TREATMENT: MANAGED CONSERVATIVELY. RETENTION OF URINE (N=2). TREATMENT: MANAGED CONSERVATIVELY. RECURRENCE OF FISTULA (N=2). TREATMENT: NOT REPORTED NEED FOR BLOOD TRANSFUSION (N=3). TREATMENT: NOT REPORTED. OPEN REPAIR GROUP 2 (N=33). UTI (N=6). TREATMENT: MANAGE CONSERVATIVELY. WOUND INFECTION (N=5). TREATMENT: MANAGE CONSERVATIVELY. ABDOMINAL DISTENTION (N=1). TREATMENT: MANAGE CONSERVATIVELY. URINARY RETENTION POST PUC REMOVAL (N=4). TREATMENT: MANAGED CONSERVATIVELY. NEED FOR BLOOD TRANSFUSION (N=3). TREATMENT: NOT REPORTED. RECURRENCE OF FISTULA (N=4). TREATMENT: 2 PATIENTS HAD ABDOMINAL HYSTERECTOMY SURGERY. IN CONCLUSIONS, LAPAROSCOPIC VVF REPAIR IS A FEASIBLE OPTION FOR PRIMARY AS WELL AS RECURRENT VVF. IT IS ASSOCIATED WITH LESS POSTOPERATIVE MORBIDITY AND COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424401 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention