BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7683110 · Received July 12, 2018

    Report

    Report Number
    2210968-2018-74311
    Event Type
    Injury
    Date Received
    July 12, 2018
    Report Date
    June 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: PLOS MED. 2011; 8(12): E1001136. DOI: 10.1371/JOURNAL.PMED.1001136. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : SURGERY VERSUS EPILATION FOR THE TREATMENT OF MINOR TRICHIASIS IN ETHIOPIA: A RANDOMISED CONTROLLED NONINFERIORITY TRIAL" AUTHOR : SAUL N. RAJAK1, ESMAEL HABTAMU2, HELEN A. WEISS1, AMIR BEDRI KELLO3, TESHOME GEBRE2, ASRAT GENET4, ROBIN L. BAILEY1, DAVID C. W. MABEY1, PENG T. KHAW5, CLARE E. GILBERT1, PAUL M. EMERSON6, MATTHEW J. BURTON1,5. CITATION: PLOS MED. 2011; 8(12): E1001136. DOI: 10.1371/JOURNAL.PMED.1001136. TRACHOMATOUS TRICHIASIS CAN CAUSE CORNEAL DAMAGE AND VISUAL IMPAIRMENT. THIS RANDOMIZED TRIAL INVESTIGATED WHETHER EPILATION IS NON-INFERIOR TO SURGERY FOR MANAGING MINOR TRICHIASIS. A TOTAL OF 1,300 INDIVIDUALS (AGE RANGE: 18 TO 70 YEARS OLD) WITH MINOR TRICHIASIS FROM AMHARA REGIONAL STATE, ETHIOPIA WERE RECRUITED AND RANDOMLY ASSIGNED TO RECEIVE TRICHIASIS SURGERY (650 PATIENTS; BMI: 2.3, 19.7¿20.1) OR EPILATION (650 PATIENTS; BMI: 2.4, 19.8¿20.2). THE POSTERIOR LAMELLA TARSAL ROTATION PROCEDURE WAS USED IN ALL SURGERY CASES. THREE SETS OF MERSILK 4-0 EVERTING SUTURES WERE PLACED TO EXTERNALLY ROTATE THE LOWER BORDER OF THE EYELID. IN THE SURGERY GROUP, REPORTED COMPLICATIONS INCLUDED PRIMARY OUTCOME FAILURE (N-14) WHICH DESCRIBED AS = 5 EYELASHES TOUCHING THE GLOBE (N-4) AND REPEAT SURGERY ELSEWHERE (N-10), INFECTION/RED EYE (N-3), INFECTION AND UNDERCORRECTION (N-1), AND BLEEDING (N-3). THE AUTHORS FOUND NO EVIDENCE THAT EPILATION IS NON-INFERIOR TO SURGERY FOR THE MANAGEMENT OF MINOR TRICHIASIS, USING A NON-INFERIORITY MARGIN OF 10% FOR THE DIFFERENCE IN CUMULATIVE RISK OF FAILURE. THE AUTHORS SUGGEST THAT SURGERY BE PERFORMED WHENEVER POSSIBLE BUT EPILATION BE USED FOR TREATMENT OF MINOR TRICHIASIS PATIENTS WITHOUT ACCESS TO OR DECLINING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526163 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention