BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15049148 · Received July 19, 2022

    Report

    Report Number
    2210968-2022-05629
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    November 8, 2021
    Report Date
    July 19, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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, 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. (B)(4). 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.  CITATION CITE: HTTPS://DOI.ORG/10.1007/S10792-021-02027-1. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS INVOLVED? PATIENT DEMOGRAPHICS? ADVERSE EVENTS WILL BE SUBMITTED VIA MW# 2210968-2022-05630.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: SURGICAL MANAGEMENT OF HELVESTON SYNDROME (TRIAD EXOTROPIA). THE PURPOSE OF THIS STUDY IS TO EVALUATE AND COMPARE DIFFERENT SURGICAL APPROACHES FOR THE TREATMENT OF HELVESTON SYNDROME AND PROVIDE FURTHER INFORMATION FOR PREOPERATIVE PLANNING. METHODS FROM FEBRUARY 2008 TO DECEMBER 2018, DATA OF 52 PATIENTS WITH HELVESTON SYNDROME WERE RETROSPEC­TIVELY REVIEWED. DIFFERENT SURGICAL APPROACHES WERE SELECTED BASED ON THE EXTENT OF A-PATTERN EXOTROPIA, DISSOCIATED VERTICAL DEVIATION (DVD), AND BOTH SUPERIOR OBLIQUE MUSCLE OVERACTION (SOOA) WITH FUNDUS PHOTOGRAPH INTORSION. EYE POSITION, A-PATTERN, DVD, SUPERIOR OBLIQUE MUSCLE FUNCTION, AND BINOCULAR VISION FUNCTION WERE EVALUATED PRE- AND POSTOPERATIVELY. THE AVERAGE FOLLOW-UP DURATION WAS 20.5 MONTHS. LATERAL RECTUS RECESSION WAS CHOSEN FOR THE CORREC­TION OF HORIZONTAL DEVIATION USING THE CONVENTIONAL METHOD WITH 6/0 VICRYL ABSORBABLE SUTURES (ETHICON) BASED ON THE DEGREE OF LATERAL DEVIATION. 5-0 NON-ABSORBABLE SUTURES (ETHICON) WERE INSERTED AND LOCKED TO THE ANTERIOR AND POSTERIOR PARTS OF THE TENDON INSERTION AND THE SLIPKNOT WAS SUTURED. REPORTED COMPLICATIONS INCLUDED A-PATTERN, DVD, SOOA, AND FUNDUS INTORSION WERE ALL COLLAPSED IN ALL PATIENTS POSTOPERATIVELY. IN CONCLUSION PECULIAR COMBINATION OF OCULAR MOTILITY DISTURBANCES, SATISFACTORY OUTCOMES CAN BE ACHIEVED IN TERMS OF DVD REDUCTION IN THE PRIMARY POSITION, AS WELL AS THE COLLAPSE OF THE A-PATTERN AND SOOA. THE SURGICAL PLANNING OF HELVESTON SYNDROME SHOULD BE DESIGNED BASED ON THE DEGREE OF THE A-PATTERN, SOOA, DVD, AND THE INTORSION IN FUNDUS PHOTOGRAPHS, AND THE APPROPRIATE APPROACH SHOULD BE SELECTED TO IMPROVE PATIENT SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699031 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other