BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 18864582 · Received March 8, 2024

    Report

    Report Number
    2210968-2024-02708
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    August 25, 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
    GR
    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. RELATED EVENTS CAPTURED VIA 2210968-2024-02707 AND 2210968-2024-02708 CITATION: JOURNAL OF BINOCULAR VISION AND OCULAR MOTILITY 2023; 73(4):115-120. HTTPS://DOI.ORG/10.1080/2576117X.2023.2241306

    Description of Event or Problem · 0

    TITLE: SHORT LOOP MODIFICATION OF THE SEMIADJUSTABLE SUTURE STRABISMUS PROCEDURE FOR OPTIONAL ADJUSTMENT THE AIM OF THIS STUDY IS TO PRESENT A MODIFICATION OF THE SEMIADJUSTABLE SUTURE TECHNIQUE ALLOWING FOR OPTIONAL ADJUSTMENT. BETWEEN DECEMBER 2019 TO MARCH 2022, A TOTAL OF 52 PATIENTS (57 RECTUS EXTRAOCULAR MUSCLES) UNDERWENT RECESSION WITH THE MODIFIED SEMIADJUSTABLE SHORT LOOP TECHNIQUE. THE MEAN AGE WAS 44.5 YEARS (RANGE: 16¿81) AND MEAN FOLLOW-UP TIME 8.8 MONTHS (RANGE 1.5¿28 MONTHS). SHORT SUTURE LOOPS BURIED UNDER CLOSED CONJUNCTIVA WERE USED INSTEAD OF THE EXPOSED LONG MUSCLE AND SLIDING NOOSE SUTURES INVOLVED IN THE STANDARD SEMIADJUSTABLE SUTURE PROCEDURE; AN ADDITIONAL TEMPORARY TRACING SUTURE FACILITATED THE RETRIEVAL OF THE BURIED MUSCLE SUTURE LOOP DURING ADJUSTMENT. A NONABSORBABLE WHITE 5¿0 MERSILENE TRACTION SUTURE WAS USED. REPORTED COMPLICATION INCLUDE PERSISTENT CONJUNCTIVAL HYPEREMIA (N=5), CONJUNCTIVAL DEHISCENCE (N=2), CONJUNCTIVAL SUTURES WERE INADVERTENTLY TEARED OUT DURING ADJUSTMENT (N=3), MILD BULGING OF CONJUNCTIVA (N=1), AND ANOTHER MILD BULGING OF CONJUNCTIVA AND SCLERAL DELLE (N=1; 55-YEAR-OLD MALE). IN CONCLUSION, THE SHORT LOOP MODIFICATION OF THE SEMIADJUSTABLE SUTURE PROCEDURE ALLOWED FOR POSTOPERATIVE ADJUSTMENT WHILE OFFERING THE BENEFIT OF MINIMAL MANIPULATION FOR THE MAJORITY OF CASES IN WHICH ADJUSTMENT WAS UNNECESSARY. NO MAJOR COMPLICATIONS IN CONJUNCTIVAL INCISION OR EXTRAOCULAR MUSCLE HEALING WERE ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881184 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention