BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND WHT 5-0 45CM S14 (2)

    MDR report key: 16130804 · Received January 10, 2023

    Report

    Report Number
    2210968-2023-00236
    Event Type
    Injury
    Date Received
    January 10, 2023
    Date of Event
    August 1, 2021
    Report Date
    January 31, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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. RELATED EVENTS CAPTURED VIA 2210968-2023-00236 AND 2210968-2023-00237. CITATION: CHINA MEDICINE AND PHARMACY (AUGUST 2021); 11(15):222-225.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 1/31/2023. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF LEVATOR MUSCLE SHORTENING COMBINED WITH TARSUS RESECTION AND FRONTALIS MUSCLE FLAP SUSPENSION IN THE TREATMENT OF MODERATE TO SEVERE PTOSIS. THE AIM OF THIS STUDY WAS TO COMPARE THE CLINICAL EFFECTS OF LEVATOR MUSCLE SHORTENING COMBINED WITH TARSUS RESECTION AND FRONTALIS MUSCLE FLAP SUSPENSION IN THE TREATMENT OF MODERATE TO SEVERE PTOSIS. A TOTAL OF 97 PATIENTS (126 EYES) WITH MODERATE TO SEVERE PTOSIS ADMITTED TO THE DEPARTMENT OF MEDICAL AESTHETICS OF THE SECOND PEOPLE'S HOSPITAL OF FOSHAN FROM JULY 2018 TO AUGUST 2020 WERE SELECTED AS STUDY SUBJECTS AND RANDOMLY DIVIDED INTO THE CONTROL GROUP (N=50, 66 EYES; 34 MALES AND 16 FEMALES, AVERAGE AGE OF 10.46 ± 10.35 [RANGE 3 TO 37] YEARS) AND THE OBSERVATION GROUP (N=47, 60 EYES; 28 MALES AND 19 FEMALES; AVERAGE AGE OF 12.97 ± 9.77 [3 TO 45] YEARS). THE CONTROL GROUP RECEIVED CORRECTION WITH FRONTALIS MUSCLE FLAP SUSPENSION, AND THE OBSERVATION GROUP RECEIVED CORRECTION WITH LEVATOR MUSCLE SHORTENING COMBINED WITH TARSUS RESECTION. IN THE CONTROL GROUP, THE FLAP IS PULLED DOWNWARD THROUGH THIS TUNNEL AND DIVIDED INTO THREE POINTS: INTERNAL, MIDDLE AND EXTERNAL 5-0 BRAID (ETHICON, INC., QAMKHT) ON EYELIDS. THE CENTRAL 1/2 OF THE PLATE WAS MATTRESS SUTURED WITH 3 TO 4 STITCHES TO THE LOWER EDGE OF THE FRONTALIS APONEUROSIS FOR OBSERVATION. THE LOCATION OF THE UPPER EYELID MARGIN IS LOCATED 0.5 MM ABOVE THE UPPER CORNEAL MARGIN AS DEGREE, NOTE THE NATURAL CURVATURE OF THE EYELID MARGIN, NO SYMBLEPHARON SEPARATION, NO LOCAL ANGULATION TRICHIASIS, KNOT TIED SUTURE FIXATION, REMOVAL OF EXCESS MUSCLE TISSUE. 7-0 POLYPROPYLENE ENENE NON-ABSORBABLE SUTURE (ETHICON, LLC, QKMKHD) INTRADERMAL SUTURE OF THE LOWER LIP OF THE DOUBLE EYELID INCISION FIXED TO THE DEEP TARSAL PLATE OF THE FRONTALIS MUSCLE FLAP. REPORTED COMPLICATIONS IN THE CONTROL GROUP INCLUDE INCOMPLETE EYE CLOSURE (N=4), HEMATOMA (N=2), AND TRICHIASIS (N=1). IN CONCLUSION, THE TREATMENT OF LEVATOR MUSCLE SHORTENING COMBINED WITH TARSUS RESECTION FOR MODERATE TO SEVERE PTOSIS IS EFFECTIVE, WHICH EXERTS COMPARABLE EFFICACY TO FRONTALIS MUSCLE FLAP SUSPENSION. BESIDES, WITH FEW AND CONTROLLABLE COMPLICATIONS AND HIGH SATISFACTION, IT 'S WORTHY OF CLINICAL APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260580 ETHIBOND WHT 5-0 45CM S14 (2) SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC. QAMKHT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other