BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL SUTURE

    MDR report key: 24801360 · Received April 7, 2026

    Report

    Report Number
    2210968-2026-03640
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    September 22, 2025
    Report Date
    April 7, 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: / NEUROL SURG B SKULL BASE. HTTPS://DOI.ORG/10.1055/A-2706-1502 ART ID JNLS-B-25-JUL-0146.

    Description of Event or Problem · 0

    TITLE: A STITCH IN TIME SAVES NINE: RETROSIGMOID CRANIOTOMY WITH LAYERED SUBOCCIPITAL MUSCLE DISSECTION TO PREVENT CEREBROSPINAL FLUID LEAK AND INFECTION THIS STUDY AIMS TO DEMONSTRATE A MODIFIED SUBOCCIPITAL MUSCLE DISSECTION TECHNIQUE FOR RSC WITH A DETAILED ANATOMICAL DESCRIPTION AND TO ASSESS ITS EFFECTIVENESS IN MINIMIZING POSTOPERATIVE WOUND COMPLICATIONS. BETWEEN JANUARY 2011 AND DECEMBER 2024, A TOTAL OF 140 CONSECUTIVE RETROSIGMOID CRANIOTOMIES PERFORMED AT OUR INSTITUTE USING THE STANDARDIZED LAYERED MUSCLE DISSECTION TECHNIQUE WERE INCLUDED. THE COHORT INCLUDED 63 MALES AND 77 FEMALES, WITH VESTIBULAR SCHWANNOMA BEING THE MOST COMMON DIAGNOSIS (73.5%). A TOTAL OF 92 PATIENTS UNDERWENT VENTRICULOPERITONEAL SHUNT BEFORE THE DEFINITIVE SURGERY. ONCE THE PROCEDURE IS COMPLETED, THE DURAL DEFECT IS CLOSED IN ALL CASES EITHER PRIMARILY OR USING A PERICRANIAL GRAFT, CONTINUOUSLY USING PROLENE 4-0. NONE OF THE PATIENTS REQUIRED ADDITIONAL ALLOGRAFTS TO OVERLAY THE DURAL DEFECT. BONE IS REPLACED IN ALL CASES AND FIXED USING MINI-PLATES AND SCREWS. THE MUSCLES ARE APPROXIMATED USING VICRYL 2-0 RB INTERRUPTED SUTURES WITHOUT TENSION, FOLLOWED BY WATERTIGHT FASCIA CLOSURE USING VICRYL 2-0 RB CONTINUOUS SUTURES. A CLOSED SUCTION DRAIN IS PLACED BETWEEN THE MUSCLE AND FASCIAL LAYER AND KEPT IN FULL SUCTION. SKIN IS APPROXIMATED WITH CLOSE MATTRESS SUTURES USING ETHILON 2-0 CB. THE MEAN FOLLOW-UP DURATION WAS 40 MONTHS. REPORTED COMPLICATIONS: PROLENE 4-0 (ETHICON): VICRYL 2-0 RB INTERRUPTED SUTURES (ETHICON): ETHILON 2-0 CB (ETHICON): (N=2) HAD PATIENTS HAD PSEUDOMENINGOCOELE TREATMENT: OF THE TWO PATIENTS WITH PSEUDOMENINGOCOELE, 1 WITH VESTIBULAR SCHWANNOMA UNDERWENT VENTRICULOPERITONEAL SHUNT AND THE OTHER 1 UNDERWENT THECOPERITONEAL SHUNT. (N=3) PATIENTS HAD CSF LEAK WITH INFECTION TREATMENT: OF THE PATIENTS WITH CSF LEAK AND INFECTION, 1 WAS MANAGED WITH LUMBAR DRAIN AND OTHER; (N=2) PATIENTS WITH MENINGIOMAS TREATMENT: REQUIRED WOUND DEBRIDEMENT. IN CONCLUSION, THE RETROSIGMOID APPROACH IS THE WORKHORSE OF POSTERIOR FOSSA TUMORS. THE LITERATURE IS ABUNDANT REGARDING VARIOUS INCISIONS, MUSCULAR DISSECTION, AND EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859851 VICRYL SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention