BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 7134805 · Received December 20, 2017

    Report

    Report Number
    2210968-2017-71884
    Event Type
    Injury
    Date Received
    December 20, 2017
    Report Date
    November 27, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. CITATION: SRI OPHTHALMOL 2005;89:64-69. DOI: 10.1136/BJO.2004.045278.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE "SURGICAL INDUCTION OF CHORIORETINAL VENOUS ANASTOMOSIS IN ISCHAEMIC CENTRAL RETINAL VEIN OCCLUSION: A NON-RANDOMISED CONTROLLED CLINICAL TRIAL¿ EVALUATED THE SAFETY AND EFFICACY OF SURGICAL INDUCTION OF CHORIORETINAL VENOUS ANASTOMOSIS IN THE MANAGEMENT OF ISCHAEMIC CENTRAL RETINAL VEIN OCCLUSION (CRVO). IN A COMPARATIVE CLINICAL TRIAL, IN THE PERIOD OF MARCH 2001 TO OCTOBER 2003, PATIENT WITH ISCHEMIC CRVO (CENTRAL RETINAL VEIN OCCLUSION) WAS INCLUDED. IN THE PROCEDURE, PATIENT UNDERWENT STANDARD VITRECTOMY WITH INCISIONS INTO THE CHOROIDS ADJACENT TO THE PARTIALLY CUT MAJOR RETINAL VEINS. THE PATIENT EXPERIENCED VITREOUS HEMORRHAGE AND UNDERWENT RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913183 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention