BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 14961084 · Received July 8, 2022

    Report

    Report Number
    2210968-2022-05292
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    December 3, 2020
    Report Date
    July 8, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: EUROPEAN JOURNAL OF OPHTHALMOLOGY 2021, VOL. 31(3) 915¿919; DOI: 10.1177/1120672120983199. PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: SURGICAL MANAGEMENT OF CONSECUTIVE EXOTROPIA: LONG-TERM OUTCOMES TO COMPARE LATERAL RECTUS RECESSION AND MEDIAL RECTUS ADVANCEMENT FOR CORRECTION OF CONSECUTIVE EXOTROPIA. BETWEEN JANUARY 1994 AND APRIL 2018, 43 PATIENTS WHO UNDERWENT LATERAL RECTUS RECESSION (LRC) AND MEDIAL RECTUS ADVANCEMENT (MRADV) FOR CORRECTION OF CONSECUTIVE EXOTROPIA WERE INCLUDED IN THE STUDY. 20 PATIENTS UNDERWENT LRC (GROUP 1) AND 23 UNDERWENT MRADV (GROUP 2). THERE WERE 10 MALE AND 10 FEMALE PATIENTS IN GROUP 1 AND 11 MALE AND 12 FEMALE PATIENTS IN GROUP 2. THE MEAN AGE OF THE PATIENTS WAS 25.30 ± 7.45 YEARS. ALL SURGICAL OPERATIONS WERE UNDERTAKEN WITH A FORNIX-BASED INCISION WITH 2 DOUBLE-ARMED 6.0 VICRYL (ETHICON) SUTURES USING HALFWIDTH, PARTIAL THICKNESS BITES, FOLLOWED BY 2 QUARTER-WIDTH AND THEN THIRD-WIDTH, FULL-THICKNESS REVERSE LOCKING BITES AT EACH EDGE WITH THE NON-ADJUSTABLE TECHNIQUE. OCULAR ALIGNMENTS WERE MEASURED AT THE SIXTH WEEK, SIXTH MONTH, FIRST YEAR AND SECOND YEAR AFTER SURGERY. THE REPORTED COMPLICATIONS INCLUDE FAILURE OF SURGERY WITH OCULAR ALIGNMENT NOT MAINTAINED WITHIN 10 PRISM DIOPTERS (N=16). IN CONCLUSION, ALTHOUGH THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE AT THE LAST FOLLOW-UP, BETTER RESULTS WERE OBTAINED WITH MEDIAL RECTUS ADVANCEMENT THAN LATERAL RECTUS RECESSION IN THE TREATMENT OF CONSECUTIVE EXOTROPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2103266 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention