BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7114580 · Received December 13, 2017

    Report

    Report Number
    2210968-2017-71765
    Event Type
    Injury
    Date Received
    December 13, 2017
    Report Date
    November 24, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (B)(4). (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. CITATION: OPHTHALMOLOGY (2017) 17:187 DOI 10.1186/S12886-017-0587-Z.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT PATIENT UNDERWENT PRIMARY PTERYGIUM SURGERY ON UNKNOWN DATE BETWEEN 09/2009 AND 10/2012 AND SUTURE WAS USED ON THE CONJUNCTIVAL ROTATION FLAP. A RETROSPECTIVE REVIEW OF THE MEDICAL RECORDS WITH INCLUSION CRITERIA WERE AN AGE EQUAL OR UNDER 80 YEARS; NO CONCURRENT OCULAR SURFACE PATHOLOGY; A MINIMUM OF 12 MONTHS OF FOLLOW-UP AFTER THE SURGERY, AND NO USE OF MITOMYCIN C. NON ABSORBABLE SUTURE WAS USED STARTING 11/2012. THE PATIENT MAY HAVE EXPERIENCED PTERYGIUM RECURRENCE WITH POSSIBLE REPAIR. TREATMENT OF THE EVENTS WAS NOT REPORTED. THE RECURRENCE RATE AFTER PTERYGIUM SURGERY IS RELATED TO SEVERAL FACTORS, SUCH AS AGE, RACE, THE CLINICAL FEATURES OF THE PTERYGIUM, SURGICAL EXPERIENCE, SUTURE MATERIAL, GLUE MATERIAL, AND THE USE OF ADJUNCTIVE AGENTS, SUCH AS MITOMYCIN C. THE AUTHORS RECOMMEND THE USE OF A NON-ABSORBABLE SUTURE MATERIAL, INSTEAD OF AN ABSORBABLE SUTURE MATERIAL IN ORDER TO FURTHER REDUCE THE RECURRENCE RATE. ADDITIONAL INFORMATION WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892979 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention