BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 16635700 · Received March 29, 2023

    Report

    Report Number
    2210968-2023-02185
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    October 20, 2021
    Report Date
    March 29, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. SHOULD FURTHER DETAILS BE PROVIDED, THE FILE WILL BE UPDATED ACCORDINGLY 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. 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 2210968-2023-02184. CITATION: OMAN J OPHTHALMOL. 2021 SEP-DEC; 14(3): 173¿178. HTTPS://DOI.ORG/10.4103/OJO.OJO_127_21.

    Description of Event or Problem · 0

    TITLE: MAXIMAL LEVATOR RESECTION VERSUS GORE-TEX® SLING FOR CONGENITAL BLEPHAROPTOSIS WITH POOR LEVATOR FUNCTION THE AIM OF THIS PROSPECTIVE STUDY WAS TO COMPARE THE OUTCOMES OF MAXIMAL LEVATOR RESECTION (MLR) WITH THOSE OF FRONTALIS SUSPENSION (FS) USING GORE-TEX®, IN THE TREATMENT OF CONGENITAL BLEPHAROPTOSIS WITH POOR LEVATOR FUNCTION. A TOTAL OF 102 EYELIDS OF 66 PATIENTS (39 MALES AND 27 FEMALES) WITH CONGENITAL PTOSIS AND POOR LPS MUSCLE FUNCTION UNDERWENT PTOSIS CORRECTION SURGERY BETWEEN (B)(6), 2016 AND (B)(6), 2019. TWENTY-EIGHT CASES (42.4%) HAD PTOSIS IN ONE EYE AND 38 CASES (57.6%) INVOLVED BOTH EYES. THE MEAN AGE WAS 4.3 ± 1.6 (RANGE 3¿8) YEARS. IN GROUP A (N=32), GORE-TEX WAS FIXED TO THE TARSUS USING 5-0 POLYESTER (ETHIBOND) SUTURES, THEN THREADED WITH A WRIGHT'S NEEDLE THROUGH THE FOREHEAD INCISIONS. IN GROUP B (N=34), A CENTRAL DOUBLE-ARMED 6-0 VICRYL SUTURE WAS PLACED FROM THE TARSAL PLATE (THREE MM BELOW THE SUPERIOR TARSAL BORDER) TO EXIT SLIGHTLY ABOVE WHITNALL'SLIGAMENT. REPORTED COMPLICATIONS INCLUDE: IN GROUP A, RECURRENCE (N=4), LAGOPHTHALMOS (N=?), LID NOTCHING (N=3), LASH PTOSIS (N=4), EXPOSURE KERATOPATHY (N=3), SLING EXTRUSION (N=1), GRANULOMA (N=6), AND SLING INFECTION (N=1). IN GROUP B, RECURRENCE (N=3), LAGOPHTHALMOS (N=?), LID NOTCHING (N=5), LASH PTOSIS (N=9), MARGIN INVERSION (N=1), EXPOSURE KERATOPATHY (N=12), AND SLING EXTRUSION (N=1). IN CONCLUSION, MLR, COMPARED TO FS WITH GORE-TEX SLING, CAN BE A MORE EFFICIENT SURGICAL OPTION TO CORRECT CONGENITAL BLEPHAROPTOSIS WITH POOR LEVATOR EXCURSION. PROMINENT POSTOPERATIVE LAGOPHTHALMOS WARRANTS CLOSE OCULAR SURFACE OBSERVATION IN EARLY FOLLOW-UP WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767275 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention