BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22192762 · Received June 12, 2025

    Report

    Report Number
    2210968-2025-06672
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    July 5, 2024
    Report Date
    June 12, 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: UROLOGY. 2024 SEP;191:110-118. HTTPS://DOI.ORG/10.1016/J.UROLOGY.2024.07.003. EPUB 2024 JUL 5. PMID: 38972397.

    Description of Event or Problem · 0

    TITLE: STOMAL STENOSIS AFTER CONTINENT URINARY DIVERSION IN BLADDER EXSTROPHY: RISK FACTORS AND MANAGEMENT. THIS RETROSPECTIVE STUDY AIMED TO IDENTIFY RISK FACTORS FOR STENOSIS AMONGST CLASSIC BLADDER EXSTROPHY (CBE) PATIENTS WITH A CONTINENT URINARY STOMA (CUS) AND REVIEW THE EFFECTIVENESS OF MANAGEMENT STRATEGIES FOR EACH ETIOLOGY. A TOTAL OF 260 CBE PATIENTS UNDERWENT CUS CREATION AT A MEDIAN AGE OF 9.9 YEARS (IQR 5.9) WITH 68.8% MALE AND THE MAJORITY WERE CAUCASIAN (83.8%). THE BLADDER WAS AUGMENTED AND THE CUS WAS CREATED USING A SIMILAR TECHNIQUE. THE CUS WAS SECURED TO THE BLADDER, THE ABDOMINAL WALL WAS CLOSED AND BOTH THE BLADDER AND CUS WERE SECURED TO THE POSTERIOR ABDOMINAL WALL USING 4-0 VICRYL.1,10 THE NEOUMBILICUS WAS CONSTRUCTED AS DESCRIBED BY HANNA USING INTERRUPTED MONOFILAMENT SUTURE, MULTIFILAMENT SUTURE OR BOTH WITH THE KNOT PLACED ON THE SKIN.11 MULTIFILAMENT SUTURE WAS PREDOMINANTLY USED EARLY IN THE STUDY PERIOD AND FROM 2006 BOTH WERE USED DEPENDING ON AVAILABILITY, WHEN BOTH SUTURE TYPES WERE USED, THE POSTERIOR APPENDIX WAS SECURED TO THE V-SHAPED SKIN FLAP WITH MULTIFILAMENT SUTURE, AND THE LATERAL AND ANTERIOR APPENDIX WERE SECURED TO THE SEMICIRCULAR SKIN FLAP WITH MONOFILAMENT SUTURE. DEEP DERMAL TISSUE AND THE SUBCUTANEOUS LAYER WERE CLOSED USING VICRYL AND CAPROSYN, RESPECTIVELY. SUTURE MATERIAL USED FOR THE UMBILICOPLASTY WAS MULTIFILAMENT ALONE IN 46.9%, MONOFILAMENT ALONE IN 26.9% AND BOTH IN 26.2%. MEDIAN FOLLOW-UP WAS 7.9 YEARS (IQR 6.7). REPORTED COMPLICATIONS INCLUDE (N=57) STENOSIS TREATED WITH CONSERVATIVE MANAGEMENT, DILATION UNDER ANESTHESIA, OR SURGICAL REVISION. IN CONCLUSION, STOMAL STENOSIS IS COMMON AND CHALLENGING FOR THE RECONSTRUCTIVE SURGEON. STRATEGIES TO PREVENT AND EFFECTIVELY MANAGE THIS ARE GREATLY DESIRED. USE OF MULTIFILAMENT SUTURE FOR THE UMBILICOPLASTY INCREASED STENOSIS PERHAPS FROM A GREATER INFLAMMATORY RESPONSE AND SCARRING, WHILE MONOFILAMENT SUTURE MAY REDUCE ITS INCIDENCE. STOMAL INCISION FOR TREATING SCAR CONTRACTURES, AND EXCISION WITH LOCAL TISSUE REARRANGEMENT FOR HYPERTROPHIC SCARS AND KELOIDS MAY IMPROVE SUCCESSFUL PRIMARY SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201562 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention