BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY PREMIUM+ PGA

    MDR report key: 15534761 · Received October 4, 2022

    Report

    Report Number
    3008912461-2022-00001
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    April 26, 2022
    Report Date
    September 21, 2022
    Manufacturer
    SM ENG CO.,LTD.
    Product Code
    GAM
    UDI-DI
    00814639021547
    PMA / PMN Number
    K161629
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE ITEM USER CONTACT OUR US AGENT AND REPORT THAT THE ITEM SEEMS TO CAUSE A INFLAMMATORY REACTION LIKE ERYTHEMA ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2929781 UNIFY PREMIUM+ PGA SURGICAL SUTURE GAM SM ENG CO.,LTD. PMGU-418R13 2103US577 00814639021547

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Prefer Not To Disclose Other