BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATHREADS

    MDR report key: 17014202 · Received May 26, 2023

    Report

    Report Number
    3007895168-2022-00060
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    July 11, 2021
    Report Date
    May 26, 2023
    Manufacturer
    ECTODERMA DBA COSMOFRANCE
    Product Code
    NEW
    PMA / PMN Number
    K191361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6)2021, HCP IMPLANTED PDO THREADS IN UPPER CHEEK + LOWER JAWLINE/NECK REGION. ON (B)(6) 2021, ACCORDING TO HCP, THE PATIENT NOTICED A PDO THREAD POKING INTO HER MOUTH. THE PATIENT PULLED ON IT AND PARTIALLY REMOVED IT. ON (B)(6)2021, THE PATIENT WAS EVALUATED BY HCP AT A FOLLOW-UP VISIT IN WHICH THE REST OF THE PDO THREAD WAS REMOVED WHICH WAS ABOUT 3-4CMS. HCP REPORTED THE PDO THREAD BROKE ABOUT MIDWAY DOWN FROM THE ZYGOMATIC ARCH OF THE PATIENT'S LEFT CHEEKBONE AND THEN IT MIGRATED OUT INTO THE PATIENT'S MOUTH. HCP REPORTED THE PATIENT SAID THAT THEY "DID EVERYTHING RIGHT" BUT NOTED AN INCREASE IN PAIN AFTER "SCRATCHING" THEIR CHEEK AND THAT SEEMS TO BE WHERE THE BREAKAGE HAPPENED. HCP PRESCRIBED PROPHYLACTIC ANTIBIOTICS SINCE THE EXPOSED PDO THREAD WAS POKING INTO THE PATIENT'S MOUTH FOR OVER 24 HOURS. HCP RECOMMENDED USUAL POST-CARE PROTOCOLS. NO ADDITIONAL INFORMATION OR STATUS OF THIS PATIENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551011 NOVATHREADS PDO SUTURE NEW ECTODERMA DBA COSMOFRANCE Y114-20

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Unknown Required Intervention