BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7674404 · Received July 10, 2018

    Report

    Report Number
    2210968-2018-74217
    Event Type
    Injury
    Date Received
    July 10, 2018
    Report Date
    June 18, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT USED IN THIS PROCEDURE? IF YES, PLEASE EXPLAIN. HAS THE COMPLAINT BEEN PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE COMPLAINT NUMBER. CITATION: CRANIOFAC SURG. 2017; 28: 831¿832. DOI: 10.1097/SCS.0000000000003517. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: WIDEMANN-RAUTENSTRAUCH SYNDROME WITH BILATERAL TARSAL KINK: THREE SUTURES FOR CORRECTION" AUTHOR: MUHAMMED BATUR, MD; ERBIL SEVEN, MD; ADNAN CINAL, MD AND TEKIN YASAR, MD CITATION: CRANIOFAC SURG. 2017; 28: 831¿832. DOI: 10.1097/SCS.0000000000003517. THIS CASE REPORT DESCRIBED A (B)(6) WHITE MALE INFANT WITH WIEDEMANN¿RAUTENSTRAUCH SYNDROME (WRS) WAS REFERRED FOR OPHTHALMOLOGIC EXAMINATION, WHICH REVEALED THIN, NARROW, SOFT TARSAL PLATES; CONGENITAL UPPER-EYELID ENTROPION WITHOUT EPIBLEPHARON; AND HORIZONTAL TARSAL KINK, WITHOUT EYELID CREASES ON BOTH EYES. DURING THE SURGICAL PROCEDURE, TRANSCONJUNCTIVALLY, A DOUBLE-ARM PROLENE 6-0 SUTURE WAS USED. TWO MILLIMETERS APART FROM EACH OTHER, THE NEEDLES WERE PASSED, GRAZING FROM THE TARSAL EDGE, THEN COMMENCING FROM THE PROXIMAL PART OF THE TARSAL PLATE, TRAVERSING ANTERIOR TO THE DISTAL PART OF THE TARSAL PLATE. THE SUTURES WERE EXITING ANTERIOR TO THE LASH LINE IN THE MID LINE OF THE RIGHT UPPER EYELID. TWO LEADS OF THE SUTURE WERE TIED AND TIGHTENED TO EVERT THE EYELID MARGIN. AFTER THAT, 2 SUTURES ALSO WERE INSERTED LATERALLY AND MEDIALLY IN THE SAME MANNER ON THE SAME UPPER EYELID. THE SAME PROCEDURE WAS DONE FOR THE LEFT UPPER EYELID. REPORTED COMPLICATIONS INCLUDED MILD BILATERAL UPPER-LID RETRACTION, WITH NO CORNEAL DISTURBANCE AND ¿¿SETTING SUN¿¿ EYES. IT WAS CONCLUDED THAT THE HORIZONTAL TARSAL KINK SYNDROME CAN BE ADEQUATELY REPAIRED BY A TRANSCONJUNCTIVAL EVERSION SUTURE WITH NO NEED OF COMPLEX AND INCISIONAL LID PROCEDURES. THE METHOD WAS SAFE, EFFECTIVE, REVERSIBLE, AND AN ALTERNATIVE TREATMENT FOR TARSAL KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515936 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention