BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 18864738 · Received March 8, 2024

    Report

    Report Number
    2210968-2024-02709
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    March 15, 2023
    Report Date
    March 8, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. CITATION: J. CLIN. MED. 2023; 12(2278):1-11. HTTPS://DOI.ORG/10.3390/JCM12062278

    Description of Event or Problem · 0

    TITLE: EFFECT OF CHANGES IN SURGICAL STRATEGIES FOR THE TREATMENT OF PRIMARY RHEGMATOGENOUS RETINAL DETACHMENT ON FUNCTIONAL AND ANATOMICAL OUTCOMES: A RETROSPECTIVE ANALYSIS OF 812 CASES FROM THE YEARS 2004 TO 2012 THIS RETROSPECTIVE STUDY AIMS TO EVALUATE CHANGES IN SURGICAL STRATEGIES OVER TIME INCLUDING THEIR IMPACT ON FUNCTIONAL AND ANATOMICAL OUTCOMES. A TOTAL OF 812 EYES FROM 812 PATIENTS TREATED FOR PRIMARY RHEGMATOGENOUS RETINAL DETACHMENT WITH EITHER ENCIRCLING SCLERAL BUCKLING, SEGMENTAL SCLERAL BUCKLING OR VITRECTOMY BETWEEN THE YEARS 2004 AND 2012 WERE INCLUDED. THE MEAN PARTICIPANT AGE AT DIAGNOSIS WAS 58.1 ± 13.3. OUT OF THESE PATIENTS, 294 WERE FEMALE (36%). STANDARD PROCEDURE FOR SCLERAL BUCKLING INCLUDES FIXATION OF SCLERAL EXPLANT WITH 4-0 MERSILENE SUTURES AND CONJUNCTIVA WAS CLOSED WITH 7-0 VICRYL SUTURES. REPORTED INTRAOPERATIVE COMPLICATIONS SUCH AS SCLERAL PERFORATION WHEN PLACING SCLERAL SUTURES (N=?). IN CONCLUSION, DATA SHOWED THAT IMPROVING FUNCTIONAL AND SINGLE-SUCCESS SURGERY OUTCOMES IN PATIENTS OPERATED ON FOR PRIMARY RRD. IN THE YEARS 2004 TO 2012, SURGICAL TECHNIQUES SHIFTED FROM SCLERAL BUCKLING TO PRIMARY VITRECTOMY AND WERE INCREASINGLY SCHEDULED DURING THE DAYTIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195956 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other