BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 18940654 · Received March 20, 2024

    Report

    Report Number
    2210968-2024-03246
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    September 30, 2021
    Report Date
    March 20, 2024
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATIONS : THE INTERNATIONAL JOURNAL ON ORBITAL DISORDERS, OCULOPLASTIC AND LACRIMAL SURGERY.VOL. 41 (5 ). 572¿580. HTTPS://DOI.ORG/10.1080/01676830.2021.1975770.

    Description of Event or Problem · 0

    TITLE : SURGICAL SUCCESS OF ¿W¿ SHAPED INCISION VERSUS TEAR TROUGH INCISION IN EXTERNAL DACRYOCYSTORHINOSTOMY. THE AIM OF THIS STUDY WAS TO COMPARE SURGICAL SUCCESS (COSMETIC, ANATOMICAL & FUNCTIONAL) OF ¿W¿ SHAPED INCISION VERSUS TEAR-TROUGH INCISION IN EXTERNAL DACRYOCYSTORHINOSTOMY (EDCR). IN A PROSPECTIVE STUDY ((B)(6) 2018 ¿ (B)(6) 2020), 61 EYES OF CHRONIC DACRYOCYSTITIS UNDERWENT EDCR RANDOMIZED INTO GROUP T (30 EYES) & GROUP W (31 EYES). THE MEAN AGE OF OUR POPULATION WAS 40.1 ± 14.9 YEARS IN BOTH THE GROUPS WITH 37.13 ± 16.48 YEARS IN GROUP T & P 42.97 ± 12.80 YEARS IN GROUP W (P = .13), WITH THE RANGE OF 7¿68 YEARS.BOTH ANTERIOR AND POSTERIOR FLAPS WERE SUTURED WHEREVER POSSIBLE WITH 6/0 VICRYL. 6/0 VICRYL WAS ALSO USED TO SUTURE THE TWO CUT ENDS OF MPL. THE SKIN INCISION WAS CLOSED USING INTERRUPTED 6/0 VICRYL SUTURES. THE REPORTED COMPLICATION INCLUDED BLEEDING FROM ANGULAR VEIN BRANCHES (N=13), BONY BLEEDING (N=2), MUCOSAL BLEEDING/INJURY (N=16), MUCOSAL FLAP TEAR DURING FASHIONING/SUTURING (N=5), SKIN FLAP BUTTON-HOLE (N=7), REVERSIBLE DARKENING OF SKIN FLAPS/INCISION SITE (N=21), EDEMA (N=31), EPIPHORA : GRADE < 2 (N=29), GRADE >2 (N=2), LAGOPHTHALMOS (N=1), SECONDARY INFLAMMATION (N=2), AND INDURATION AT SUTURE SITE (N=6). IN CONCLUSION, SURGICAL SUCCESS IN TERMS OF COSMETIC, ANATOMICAL & FUNCTIONAL OUTCOMES OF W-SHAPED INCISION WERE COMPARABLE TO THE CONVENTIONAL TEAR TROUGH INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493845 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention