BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS

    MDR report key: 6923150 · Received October 6, 2017

    Report

    Report Number
    3005619263-2017-00053
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    August 4, 2017
    Report Date
    August 4, 2017
    Manufacturer
    TRYX, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PURULENT DRAINAGE WAS COMING FROM THE POCKET SITE. THE DEVICE AND LEADS WERE EXPLANTED AND REPLACED FOUR DAYS LATER. THE PATIENT ALSO HAD AN ABSORBABLE ANTIBACTERIAL ENVELOPE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701869 AIGIS MESH, SURGICAL, POLYMERIC FTL TRYX, INC. TYRX-AE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R 6935M62 LEAD, 5076-52 LEAD, 4298 LEAD, DTMB1QQ ICD