BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 16102836 · Received January 5, 2023

    Report

    Report Number
    2210968-2023-00093
    Event Type
    Injury
    Date Received
    January 5, 2023
    Date of Event
    January 1, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ACTA OPHTHALMOLOGICA 2021: 99: E109¿E116. DOI: 10.1111/AOS.14528.

    Description of Event or Problem · 0

    TITLE: PNEUMATIC RETINOPEXY PRECEDED BY DRAINAGE OF SUBRETINAL FLUID FOR THE TREATMENT OF SEVERE BULLOUS RETINAL DETACHMENT. THIS PROSPECTIVE, RANDOMIZED, COMPARATIVE STUDY AIMED TO COMPARE THE EFFICACY AND SAFETY OUTCOMES OF SCLERAL BUCKLING (SB) AND DRAINAGE¿INJECTION¿PNEUMORETINOPEXY (DIP), A MODIFIED PNEUMATIC RETINOPEXY TECHNIQUE, IN WHICH, BEFORE GAS INJECTION, SUBRETINAL FLUID IS DRAINED WITH A SIMULTANEOUS INJECTION OF BALANCED SALT SOLUTION (BSS) IN THE VITREOUS CHAMBER, FOR THE TREATMENT OF SEVERE SUPERIOR BULLOUS RHEGMATOGENOUS RETINAL DETACHMENT (SBRD). A TOTAL OF 58 EYES IN 58 PATIENTS WITH SBRD WHO UNDERWENT SB (N=27; 9 WERE FEMALES; MEAN AGE OF 50.6 (13.2) YEARS ) OR DIP (N=27; 11 WERE FEMALES; MEAN AGE OF 51 (11.8) YEARS) BETWEEN MARCH 2017 AND MARCH 2019 WERE INCLUDED. THE 5-0 MERSILENE SUTURE WAS USED IN SCLERAL BUCKLING (SB) GROUP TO SUTURE THE 2-MM-WIDTH SILICONE ENCIRCLING BAND TO THE FOUR QUADRANTS OF THE SCLERA. THE VICRYL 6-0 THREAD WAS USED IN DIP GROUP, PASSING THROUGH THE SCLERA, TO FACILITATE SURGICAL MANOEUVRES. REPORTED COMPLICATIONS INCLUDE: IN SB GROUP - DIPLOPIA (N=3); MILD POSTOPERATIVE PTOSIS (N=2) WHICH WAS DUE TO A RADIAL SEGMENTAL BUCKLE (SILICON TIRES) THAT HAD BEEN PLACED IN THE UPPER SECTORS: THE TRACTION EXERTED BY THE SURGICAL MANOEUVRES ON THE UPPER RECTUS MUSCLE MIGHT HAVE CAUSED A WEAKENING OF THE UPPER EYELID LEVATOR MUSCLE; AND UNINTENTIONAL PERFORATION OF THE SCLERA DURING THE SUTURE OF THE BUCKLE (N=2) IN CONCLUSION, THEIR FINDINGS SUGGESTED THAT BOTH SB AND DIP ARE SAFE AND EFFECTIVE TREATMENTS YIELDING FUNCTIONAL AND ANATOMICAL RECOVERY IN PATIENTS WITH SEVERE SBRD. HOWEVER, THE DIP TECHNIQUE MAY BE EASIER AND LESS COSTLY, WITH A SUCCESS RATE SIMILAR TO THAT OF SB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645483 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other