BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22168912 · Received June 9, 2025

    Report

    Report Number
    2210968-2025-06505
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    August 9, 2024
    Report Date
    June 9, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 (01) GTIN IS NOT AVAILABLE. CITATION: J PLAST RECONSTR AESTHET SURG. 2024 NOV;98:55-63. HTTPS://DOI.ORG/10.1016/J.BJPS.2024.08.047. EPUB 2024 AUG 15. PMID: 39236396.

    Description of Event or Problem · 0

    A COMPARATIVE ANALYSIS OF PERITONEAL FLAP AND INTESTINAL VAGINOPLASTY FOR MANAGEMENT OF VAGINAL STENOSIS. THIS RETROSPECTIVE COHORT STUDY AIMS TO COMPARE THE SAFETY AND EFFICACY OF REVISION PERITONEAL FLAP VAGINOPLASTY (PFV) AND SEGMENT VAGINOPLASTY (ISV) IN TRANSGENDER OR NON-BINARY PATIENTS (TGNB) PATIENTS AFTER FAILED PENILE INVERSION VAGINOPLASTY (PIV). BETWEEN DECEMBER 2018 TO APRIL 2023, A TOTAL OF 45 PATIENTS WHO EXPERIENCED VAGINAL STENOSIS UNDERWENT SECONDARY PFV (N=21) WHILE USING BARBED MONOCRYL 3¿0 AND 4¿0 SUTURES AND SECONDARY ISV (N=24) WHILE USING VICRYL 3¿0 SUTURE. REPORTED COMPLICATIONS ARE BARBED MONOCRYL 3¿0 AND 4¿0 PFV GROUP (N=21) INTROITAL DEHISCENCE (N = 2) TREATMENT: MANAGED CONSERVATIVELY URINARY TRACT INFECTION (N = 2) TREATMENT: MANAGED CONSERVATIVELY PROLAPSE (N = 1) TREATMENT: NOT REPORTED VAGINAL STENOSIS (N = 9) TREATMENT: REVISION VAGINOPLASTY (N=5) VAGINAL BLEEDING (N = 2) TREATMENT: MANAGED CONSERVATIVELY, STEROID CREAM IF TRAUMATIC IN NATURE, AND WITH VAGINAL DOUCHING USING SHORT-CHAIN FATTY ACIDS IF DUE TO DIVERSION COLITIS VAGINAL STENT DISPLACEMENT (N = 1) TREATMENT: REQUIRING LAPAROSCOPIC REMOVAL GRANULATION TISSUE FORMATION (N = 1) TREATMENT: REQUIRING DEBRIDEMENT HYPERGRANULATION (N = 2) TREATMENT: NOT REPORTED INTROITAL STENOSIS DUE TO KELOID FORMATION (N = 1) TREATMENT: EXCISION MUCOSAL PROLAPSE (N = 1) TREATMENT: MUCOSAL SLEEVE RESECTION WITH FIXATION OF THE LATERAL COLONIC WALLS TO THE PELVIC FLOOR MUSCLES LATE URETHROVAGINAL FISTULA (UVF) FORMATION (N=1) TREATMENT: CLOSED WITH A GRACILIS FLAP VICRYL 3¿0 SUTURE ISV GROUP (N=24) DEHISCENCE (N = 4) TREATMENT: MANAGED CONSERVATIVELY ILEUS (N = 2) TREATMENT: NOT REPORTED VAGINAL BLEEDING (N=1) TREATMENT: FLEXIBLE SIGMOIDOSCOPY UNDER ANESTHESIA AND TRANSECTION OF A SEGMENT OF ISCHEMIC SIGMOID COLON HYPERGRANULATION (N = 1) TREATMENT: MANAGED CONSERVATIVELY INTROITAL STENOSIS (N = 5) TREATMENT: MANAGED WITH PELVIC FLOOR THERAPY (N=1), REQUIRING REOPERATION (N=2) URETHRAL STENOSIS CAUSED BY RESIDUAL ERECTILE TISSUE (N = 1) TREATMENT: REQUIRING REMOVAL MUCOSAL PROLAPSE (N = 2) TREATMENT: REQUIRING ROBOTIC RECTOPEXY IN CONCLUSION, REVISION PFV AND ISV ARE FEASIBLE VAGINOPLASTY TECHNIQUES FOR ADDRESSING COMPLICATIONS AFTER FAILED PIV. ISV DEMONSTRATES A LOWER INCIDENCE OF RECURRENT VAGINAL STENOSIS AND HIGHER RATES OF REOPERATION DUE TO PROLAPSE, WHICH MAY PROVIDE BETTER INFORMATION FOR OPERATIVE DECISION-MAKING. IT IS CRUCIAL TO CAREFULLY CONSIDER THE INDIVIDUAL PATIENT¿S EXPECTATIONS AND NEEDS WHEN SELECTING THE OPTIMAL REVISION METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633186 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention