BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 8338727 · Received February 14, 2019

    Report

    Report Number
    2210968-2019-78876
    Event Type
    Injury
    Date Received
    February 14, 2019
    Report Date
    January 23, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CITATION: STRABISMUS. 2008; 16: 77¿83. DOI: 10.1080/09273970802077474. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: TRACTION SUTURES IN THE MANAGEMENT OF LONG-STANDING THIRD NERVE PALSY." AUTHORS: AYMAN KHAIER, MSC FRCSED; EMMA DAWSON, DBO; JOHN LEE, FRCS FRCOPHTH. CITATION: STRABISMUS. 2008; 16: 77¿83. DOI: 10.1080/09273970802077474. EXOTROPIA IN LONG-STANDING THIRD NERVE PALSY PRESENTS A SIGNIFICANT COSMETIC PROBLEM AND THE MANAGEMENT IS DIFFICULT. METHOD: A RETROSPECTIVE REVIEW OF 33 PATIENTS (20 FEMALE AND 13 MALE PATIENTS; AGE RANGE: 3 TO 66 YEARS OLD) WITH LONG-STANDING EXOTROPIA SECONDARY TO THIRD NERVE PALSY BETWEEN 1996 AND 2006 WAS CARRIED OUT. DURING THE SURGICAL PROCEDURE, TWO ETHIBOND 6-0 SUTURES (ETHICON) ARE THEN PASSED THROUGH THE INSERTION OF THE SUPERIOR AND INFERIOR RECTUS MUSCLES RIGHT NEXT TO THE SCLERA AND TAKEN THROUGH THE UPPER AND LOWER FORNICES TO THE MEDIAL CANTHUS WHERE THEY ARE BROUGHT TO THE SURFACE THROUGH THE LID SKIN BY MEANS OF A LARGE ½ CIRCLE CUTTING EDGE EYED NEEDLE. THE TRACTION SUTURES ARE THEN PULLED UP TO BRING THE EYE INTO ADDUCTION AND ARE THEN TIED OVER PLASTIC BOLSTERS. TRACTION SUTURES ARE LEFT IN SITU FOR SIX WEEKS. REMOVAL OF THESE SUTURES IS DONE IN THE CLINIC AND IS EASILY TOLERATED BY PATIENTS NO MATTER THE AGE. REPORTED COMPLICATIONS INCLUDED: CASE 1, A (B)(6) PATIENT WITH CORNEAL ULCER, CASE 3, A (B)(6) PATIENT WITH INTRACTABLE DIPLOPIA WHICH REQUIRED AN OCCLUSIVE CONTACT LENS, CASE 4, A (B)(6) PATIENT WITH CORNEAL ULCER, CASE 11, A (B)(6) PATIENT WITH SUTURE GRANULOMA, CASE 15, A (B)(6) PATIENT WITH CONJUNCTIVAL HYPERTROPHY WHICH REQUIRED EXCISION AND SQUINT SURGERY, SUTURE INFECTION (N-2) WHICH REQUIRED REMOVAL OF TRACTION SUTURES, CONJUNCTIVAL HYPERTROPHY (N-3) WHICH REQUIRED REMOVAL OF TRACTION SUTURES IN 1 PATIENT AND DOES NOT REQUIRE SUTURE REMOVAL IN 2 PATIENTS, SUTURE GRANULOMA (N-2), INTRACTABLE DIPLOPIA (N-1) WHICH REQUIRED OCCLUSIVE CONTACT LENS. IN TOTAL THIRD CRANIAL NERVE PALSY, IT IS PRACTICALLY IMPOSSIBLE TO ACHIEVE A SUCCESSFUL FUNCTIONAL OUTCOME BECAUSE THE EXTENT OF MUSCLE INVOLVEMENT MAKES IT DIFFICULT TO MAINTAIN MOTOR FUSION IN THESE PATIENTS AND THEREFORE TO CONTROL THEIR DIPLOPIA SATISFACTORILY. LARGE LATERAL RECTUS RECESSION AND MEDIAL RECTUS RESECTION COMBINED WITH MUSCLE TRACTION SUTURES ARE EFFECTIVE IN TREATING EXOTROPIA IN THIRD CRANIAL NERVE PALSY WITH GOOD COSMESIS AND LONG STABILITY. PATIENTS ARE PLEASED WITH THE OUTCOME; AND THE EXTENT OF POST-OPERATIVE LIMITATION OF ABDUCTION CAN PREDICT THE FINAL EYE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132819 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention