BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMEDIOX

    MDR report key: 19281936 · Received May 9, 2024

    Report

    Report Number
    3007895168-2024-00007
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    April 4, 2024
    Report Date
    May 7, 2024
    Manufacturer
    DEMETECH CORPORATION
    Product Code
    NEW
    UDI-DI
    10652927777489
    PMA / PMN Number
    K082097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. THE REPORT REPRESENTS A CORRECTION TO A PREVIOUSLY SUBMITTED MDR 3007895168-2024-00007. BRAND NAME: DEMEDIOX. VERSION OR MODEL: PX2X783090A16MB. COMPANY NAME: DEMETECH CORPORATION. PRIMARY DI NUMBER: (B)(4). DEVICE DESCRIPTION: ABSORBABLE POLYDIOXANONE SURGICAL SUTURE. FDA PREMARKET SUBMISSION NUMBER: K082097.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE PATIENT REPORTED THAT THEY HAD PDO THREADS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, ACCORDING TO THE HCP, PATIENT EXPERIENCED PAIN WITH THE THREAD POKING UNDER THE SKIN AT THE ENDPOINT IN THE MIDDLE OF THE NECK. DURING THE FOLLOW-UP, PATIENT WAS INJECTED WITH HYALURONIC ACID BY THE HCP TO SOFTEN THE THREAD. ACCORDING TO THE HCP, PATIENT PRESENTED NO CHANGES TWO WEEKS LATER. PATIENT EXPERIENCED ANOTHER PDO THREAD MIGRATED FROM THE JAWLINE INTO THE CHIN. HCP EXTRACTED THE THREAD AND ATTEMPTED TO REMOVE ANOTHER THREAD AT THE THYROID CARTILAGE ASPECT BUT WAS UNSUCCESSFUL. PATIENT WAS INJECTED WITH HYALURONIC ACID BY THE HCP AGAIN TO SOFTEN THE THREAD. ON (B)(6) 2024, HCP WAS INFORMED BY THE PATIENT THAT THE THREAD HAD EXTRUDED OUT. ON (B)(6) 2024, THE HCP CONFIRMED THAT THE PATIENT IS CURRENTLY IN GOOD CONDITION.

    Description of Event or Problem · 0

    ON (B)(6), 2024, THE PATIENT REPORTED THAT THEY HAD PDO THREADS IMPLANTED ON (B)(6) 2024. ON (B)(6), 2024, ACCORDING TO THE HCP, PATIENT EXPERIENCED PAIN WITH THE THREAD POKING UNDER THE SKIN AT THE ENDPOINT IN THE MIDDLE OF THE NECK. DURING THE FOLLOW-UP, PATIENT WAS INJECTED WITH HYALURONIC ACID BY THE HCP TO SOFTEN THE THREAD. ACCORDING TO THE HCP, PATIENT PRESENTED NO CHANGES TWO WEEKS LATER. PATIENT EXPERIENCED ANOTHER PDO THREAD MIGRATED FROM THE JAWLINE INTO THE CHIN. HCP EXTRACTED THE THREAD AND ATTEMPTED TO REMOVE ANOTHER THREAD AT THE THYROID CARTILAGE ASPECT BUT WAS UNSUCCESSFUL. PATIENT WAS INJECTED WITH HYALURONIC ACID BY THE HCP AGAIN TO SOFTEN THE THREAD. ON (B)(6), 2024, HCP WAS INFORMED BY THE PATIENT THAT THE THREAD HAD EXTRUDED OUT. ON (B)(6), 2024, THE HCP CONFIRMED THAT THE PATIENT IS CURRENTLY IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274591 DEMEDIOX ABSORBABLE POLYDIOXANONE SURGICAL SUTURE NEW DEMETECH CORPORATION PX2X783090A16MB L107-22 10652927777489

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention