BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 8358732 · Received February 21, 2019

    Report

    Report Number
    2210968-2019-78984
    Event Type
    Injury
    Date Received
    February 21, 2019
    Report Date
    January 28, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (ETHIBOND, OR VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON? CITATION: J CRANIOFAC SURG 2016; 27: 198¿200; DOI: 10.1097/SCS.0000000000002287.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: COMPARISON OF SURGICAL OUTCOME BETWEEN QUICKERT SUTURE AND QUICKERT SUTURE WITH MODIFIED LATERAL TARSAL STRIP IN INVOLUTIONAL LOWER EYELID ENTROPION. AUTHOR(S): JI SUN BAEK, MD, SEONG CHAN CHOI, MD, SUN YOUNG JANG, MD, JUNG HYE LEE, MD, AND HYE SUN CHOI, MD. CITATION: J CRANIOFAC SURG 2016; 27: 198¿200; DOI: 10.1097/SCS.0000000000002287. THIS RETROSPECTIVE REVIEW AIMED TO EVALUATE THE SURGICAL OUTCOME BETWEEN QUICKERT SUTURE AND QUICKERT SUTURE WITH MODIFIED LATERAL TARSAL STRIP IN INVOLUTIONAL LOWER EYELID ENTROPION. FROM JAN2011 TO DEC2013, 114 PATIENTS OF 138 EYES UNDERWENT SURGERY FOR CORRECTING THE INVOLUTIONAL ENTROPION USING QUICKERT SUTURE (N=76 PATIENTS OF 94 EYES) AND QUICKERT SUTURE WITH MODIFIED LATERAL TARSAL STRIP (N=38 PATIENTS OF 44 EYES). IN QUICKERT SUTURE GROUP (GROUP 1), A TOTAL OF 3 OR 4 SUTURES WERE INSERTED THROUGH THE DEEP CONJUNCTIVA WITHIN THE INFERIOR CONJUNCTIVAL FORNIX WITH 6-0 VICRYL. IN QUICKERT SUTURE WITH MODIFIED LATERAL TARSAL STRIP GROUP (GROUP 2), A TOTAL OF 3 OR 4 SUTURES WERE INSERTED, THROUGH THE DEEP CONJUNCTIVA, WITHIN THE INFERIOR CONJUNCTIVAL FORNIX WITH 6¿0 VICRYL. THE 5¿0 ETHIBOND SUTURES ARE PASSED THROUGH TARSUS AT THE EDGE OF THE EXCISED EYELID MARGIN AND SUTURED TO THE LATERAL ORBITAL RIM IN A SLIGHTLY UPWARD POSITION. AT THE FOLLOW-UP PERIOD, RECURRENCE OF INVOLUTIONAL ENTROPION WAS REPORTED IN GROUP 1 (N=4) WHICH WAS TREATED WITH ADDITIONAL QUICKERT SUTURE (N=12), QUICKERT SUTURE WITH LATERAL TARSAL STRIP (N=9) AND LATERAL TARSAL STRIP (N=3). IN GROUP 2, RECURRENCE OF INVOLUTIONAL ENTROPION WAS REPORTED (N=4) WHICH WAS TREATED WITH QUICKERT SUTURE (N=1), QUICKERT SUTURE WITH LATERAL TARSAL STRIP (N=1) AND LOWER LID RETRACTOR REINSERTION (N=2). OVERRIDING OF THE PRESEPTAL ORBICULARIS MUSCLE, HORIZONTAL EYELID LAXITY AND DEHISCENCE OF LOWER EYELID RETRACTOR IS KNOWN TO CAUSE THE INVOLUTIONAL ENTROPION. CORRECTION OF HORIZONTAL EYELID LAXITY MIGHT BE NEEDED FOR REDUCING THE RECURRENCE RATE OF QUICKERT SUTURE. THE COMBINATION OF QUICKERT SUTURE WITH MODIFIED LATERAL TARSAL STRIP IS AN EFFECTIVE METHOD TO TREAT INVOLUTIONAL ENTROPION BY CORRECTION OF HORIZONTAL AND VERTICAL EYELID LAXITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152074 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention