BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICLED SURGICAL SUTURE SYSTEM

    MDR report key: 20096405 · Received August 29, 2024

    Report

    Report Number
    1222993-2024-00045
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    July 31, 2024
    Report Date
    August 29, 2024
    Manufacturer
    CYNOSURE LLC
    Product Code
    GAT
    PMA / PMN Number
    K230510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CYNOSURE'S CLINICAL TEAM INVESTIGATED THE EVENT AND DETERMINED IT WAS INCONCLUSIVE. PUSTULES AND BREAKOUT WAS OBSERVED ADJACENT TO THE INVOLVED UNDERMINED REGIONS OF MYELLEVATE SUTURE. PER CYNOSURE'S KOL PHYSICIAN: IT APPEARS TO BE A CONTACT INFECTION COMPLICATED WITH A SUPERFICIAL INFECTION. THE AREA OF INFECTIONS IS MOSTLY OUTSIDE THE UNDERMINED SKIN. PATIENT WAS GIVEN DOXYCYCLINE AND BACTROBAN AS MEDICAL INTERVENTION. THIS IS A REPORTABLE ADVERSE EVENT DUE TO PATIENT RECEIVING MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED BREAKOUT WITH PUSTULES SPREADING ON THE SUBMENTAL AREA 2 DAYS POST MYELLEVATE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523094 ICLED SURGICAL SUTURE SYSTEM ICLED SURGICAL SUTURE SYSTEM GAT CYNOSURE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention