BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS

    MDR report key: 4969155 · Received August 5, 2015

    Report

    Report Number
    2182208-2015-02606
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    May 29, 2015
    Report Date
    February 18, 2019
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SYSTEM UPGRADE AND AN ABSORBABLE ENVELOPE WAS IMPLANTED. APPROXIMATELY ONE MONTH LATER THE PATIENT PRESENTED TO THE HOSPITAL WITH A POCKET INFECTION. THE SYSTEM WAS EXPLANTED AND REPLACED ON THE OTHER SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513066 AIGIS MESH, SURGICAL, POLYMERIC FTL TYRX, INC. TYRX-AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| R