BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMEDIOX

    MDR report key: 23817668 · Received December 16, 2025

    Report

    Report Number
    3007895168-2025-00003
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    September 18, 2025
    Report Date
    November 6, 2025
    Manufacturer
    DEMETECH CORPORATION
    Product Code
    NEW
    UDI-DI
    10652927697879
    PMA / PMN Number
    K082097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025, A HEALTHCARE PROVIDER (HCP) REPORTED THAT A PATIENT PRESENTED WITH PALPABLE PDO BARB THREADS BENEATH THE SKIN ALONG THE RIGHT MANDIBLE. THE THREADS WERE NOT EXTERNALLY VISIBLE. THE HCP NOTED A LOCALIZED ELEVATION AT THE SITE WITH NO ERYTHEMA, DRAINAGE, OR TENDERNESS OBSERVED. THE HCP ATTEMPTED TO ACCESS THE AREA USING AN 18G NEEDLE TO REMOVE OR TRIM THE THREADS; HOWEVER, THE REMOVAL ATTEMPT WAS UNSUCCESSFUL. THE HCP REQUESTED MEDICAL GUIDANCE. ON (B)(6) 2025, THE MEDICAL DIRECTOR PROVIDED INSTRUCTIONS TO UTILIZE THE THREADMATE TOOL AND SUPPLIED THREAD-REMOVAL INSTRUCTIONAL MATERIALS. ON (B)(6) 2025, A FOLLOW-UP WAS CONDUCTED TO OBTAIN UPDATED INFORMATION REGARDING THE PATIENT AND TO DETERMINE WHETHER THREAD REMOVAL WAS SUCCESSFUL. THE HCP REPORTED THAT THEY WERE UNABLE TO VISUALIZE THE THREADS AND THAT REMOVAL ATTEMPTS REMAINED UNSUCCESSFUL. THE HCP REQUESTED ADDITIONAL MEDICAL GUIDANCE. THE MEDICAL DIRECTOR SUBSEQUENTLY OFFERED TO EVALUATE THE PATIENT IN PERSON THROUGH A CONSULTATION. AT THE TIME OF THIS REPORT, NO INFECTION, DRAINAGE, OR ADVERSE SYSTEMIC SYMPTOMS HAVE BEEN REPORTED. PATIENT OUTCOME REMAINS UNCHANGED, AND MEDICAL EVALUATION IS PENDING. UPDATE WILL BE PROVIDED IF AND WHEN IT BECOMES AVAILABLE. UPDATE: ON JANUARY 5, 2026, A FOLLOW-UP EMAIL WAS SENT TO THE HCP REQUESTING AN UPDATE ON THE PATIENT'S CONDITION AND WHETHER THE PDO THREADS HAD BEEN SUCCESSFULLY REMOVED. THE HCP REPLIED TO THE PRIOR COMMUNICATION STATING: "BASED ON SOME ANECDOTAL LITERATURE, WE DECIDED TO INJECT HYLENEX, WHICH WORKED, AND THE PATIENT IS HAPPY." THIS CASE IS CONFIRMED TO BE CLOSED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A HEALTHCARE PROVIDER (HCP) REPORTED THAT A PATIENT PRESENTED WITH PALPABLE PDO BARB THREADS BENEATH THE SKIN ALONG THE RIGHT MANDIBLE. THE THREADS WERE NOT EXTERNALLY VISIBLE. THE HCP NOTED A LOCALIZED ELEVATION AT THE SITE WITH NO ERYTHEMA, DRAINAGE, OR TENDERNESS OBSERVED. THE HCP ATTEMPTED TO ACCESS THE AREA USING AN 18G NEEDLE TO REMOVE OR TRIM THE THREADS; HOWEVER, THE REMOVAL ATTEMPT WAS UNSUCCESSFUL. THE HCP REQUESTED MEDICAL GUIDANCE. ON NOVEMBER 10, 2025, THE MEDICAL DIRECTOR PROVIDED INSTRUCTIONS TO UTILIZE THE THREADMATE TOOL AND SUPPLIED THREAD-REMOVAL INSTRUCTIONAL MATERIALS. ON DECEMBER 8, 2025, A FOLLOW-UP WAS CONDUCTED TO OBTAIN UPDATED INFORMATION REGARDING THE PATIENT AND TO DETERMINE WHETHER THREAD REMOVAL WAS SUCCESSFUL. THE HCP REPORTED THAT THEY WERE UNABLE TO VISUALIZE THE THREADS AND THAT REMOVAL ATTEMPTS REMAINED UNSUCCESSFUL. THE HCP REQUESTED ADDITIONAL MEDICAL GUIDANCE. THE MEDICAL DIRECTOR SUBSEQUENTLY OFFERED TO EVALUATE THE PATIENT IN PERSON THROUGH A CONSULTATION. AT THE TIME OF THIS REPORT, NO INFECTION, DRAINAGE, OR ADVERSE SYSTEMIC SYMPTOMS HAVE BEEN REPORTED. PATIENT OUTCOME REMAINS UNCHANGED, AND MEDICAL EVALUATION IS PENDING. UPDATE WILL BE PROVIDED IF AND WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942522 DEMEDIOX ABSORBABLE POLYDIOXANONE SURGICAL SUTURE NEW DEMETECH CORPORATION PX2X46800100A16B J191-24 10652927697879

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other