BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7346596 · Received March 16, 2018

    Report

    Report Number
    2210968-2018-71507
    Event Type
    Injury
    Date Received
    March 16, 2018
    Report Date
    March 5, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON VICRYL SUTURES CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? WAS THERE ANY ALLEGED DEFICIENCY RELATING TO ETHICON VICRYL SUTURES? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? IF YES, PLEASE INCLUDE: DATE OF PROCEDURE, WHERE PROCEDURE WAS PERFORMED, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, PRODUCT INVOLVED, PRE-EXISTING CONDITIONS. PRODUCT CODE AND LOT NUMBER OF PRODUCT USED?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: LONG-TERM COMPARISON OF FIBRIN TISSUE GLUE AND VICRYL SUTURE IN CONJUNCTIVAL AUTOGRAFTING FOR PTERYGIUM SURGERY AUTHOR(S): HALIL HUSEYIN CAGATAY, MD, GOKCEN GOKCE, MD, METIN EKINCI, MD, YARAN KOBAN, MD, OZLEM DARAMAN, MD, ERDINÇ CEYLAN, MD CITATION: POSTGRADUATE MEDICINE (2014), 126:1, 97-103, DOI: 10.3810/PGM.2014.01.2729 THE PURPOSE OF THIS RETROSPECTIVE, COMPARATIVE STUDY WAS TO COMPARE VISUAL AND REFRACTIVE OUTCOMES, COMPLICATIONS, AND RECURRENCE RATES WITH THE USE OF FIBRIN GLUE VERSUS 8.0 VICRYL SUTURE IN PTERYGIUM SURGERY PERFORMED WITH CONJUNCTIVAL AUTOGRAFT. BETWEEN 2011 AND 2012, 106 EYES OF 106 PATIENTS WITH PRIMARY PTERYGIUM UNDERWENT SURGERY WITH CONJUNCTIVAL AUTOGRAFT. THE PATIENTS WERE DIVIDED INTO TWO TREATMENT GROUPS FOR CONJUNCTIVAL AUTOGRAFT: VICRYL SUTURE PATIENTS AS GROUP 1 (N=53; N=21 MALE, N=32 FEMALE; MEAN AGE SD 53.75±10.7 YEARS) AND FIBRIN TISSUE GLUE AS GROUP 2 (N=53; N=17 MALE, N=36 FEMALE; MEAN AGE SD 52.08±12.8). IN GROUP 1, THE CONJUNCTIVA WERE ATTACHED WITH INTERRUPTED 8.0 VICRYL SUTURES. IN GROUP 1, POSTOPERATIVE COMPLICATIONS INCLUDED TENON¿S CYST (N=3), DEHISCENCE (N=4), AND CORNEAL EPITHELIOPATHY (N=3). ALL DEHISCENT GRAFTS WERE RE-ATTACHED IN A SECOND SURGERY. CORNEAL EPITHELIOPATHY WERE TREATED WITH LUBRICATING DROPS. TENON¿S CYST FORMATION WERE EXCISED IN A SECOND SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187573 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention