BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMEDIOX

    MDR report key: 19561695 · Received June 18, 2024

    Report

    Report Number
    3007895168-2024-00010
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 10, 2024
    Report Date
    June 10, 2024
    Manufacturer
    DEMETECH CORPORATION
    Product Code
    NEW
    UDI-DI
    10652927777489
    PMA / PMN Number
    K082097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: THE REPORT REPRESENTS A CORRECTION TO A PREVIOUSLY SUBMITTED MDR 3007895168-2024-00010-001 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: (B)(4).

    Description of Event or Problem · 0

    04/22/2024, HCP REPORTED TO THE SALES REPRESENTATIVE THAT THE PATIENT HAD ONE THREAD POKING OUT FROM INSIDE OF THE MOUTH. ACCORDING TO THE HCP, THREAD WAS REMOVED BY THE PATIENT AT HOME. PATIENT REPORTED INTENSE PAIN AT THE DISTAL END OF THE THREAD AND HEARING A "SNAP" SOUND WHEN MOVING. PATIENT ALSO REPORTED FEELING THE THREADS MIGRATE UNDER THE SKIN. AT THE HCP'S CLINIC, PATIENT PRESENTED WITH THREE THREADS POKING FROM UNDER THE SKIN, TWO FROM THE RIGHT SIDE OF THE FACE (NLF AND CHIN), AND ONE RIGHT ON THE PATIENT'S LEFT PYRIFORM AREA. HCP REMOVED TWO THREADS ON THE RIGHT SIDE. HCP ATTEMPTED TO REMOVE THE THIRD THREAD ON THE PATIENT'S LEFT SIDE, BUT WAS UNSUCCESSFUL. 06/12/2024, HCP REPORTED THAT THE PATIENT IS FINE AND NO ADDITIONAL FOLLOW-UP WAS NEEDED.

    Description of Event or Problem · 0

    04/22/2024, HCP REPORTED TO THE SALES REPRESENTATIVE THAT THE PATIENT HAD ONE THREAD POKING OUT FROM INSIDE OF THE MOUTH. ACCORDING TO THE HCP, THREAD WAS REMOVED BY THE PATIENT AT HOME. PATIENT REPORTED INTENSE PAIN AT THE DISTAL END OF THE THREAD AND HEARING A "SNAP" SOUND WHEN MOVING. PATIENT ALSO REPORTED FEELING THE THREADS MIGRATE UNDER THE SKIN. AT THE HCP'S CLINIC, PATIENT PRESENTED WITH THREE THREADS POKING FROM UNDER THE SKIN, TWO FROM THE RIGHT SIDE OF THE FACE (NLF AND CHIN), AND ONE RIGHT ON THE PATIENT'S LEFT PYRIFORM AREA. HCP REMOVED TWO THREADS ON THE RIGHT SIDE. HCP ATTEMPTED TO REMOVE THE THIRD THREAD ON THE PATIENT'S LEFT SIDE, BUT WAS UNSUCCESSFUL. 06/12/2024, HCP REPORTED THAT THE PATIENT IS FINE AND NO ADDITIONAL FOLLOW-UP WAS NEEDED. UPDATE: ON 06/26/2024, HCP WAS CONTACTED TO PROVIDE PICTURES OF THE PATIENT AND ADDITIONAL INFORMATION REGARDING THE IMPLANTED AND REMOVAL DATE OF THE THREADS. ON 06/27/2024, HCP PROVIDED PICTURES OF THE PATIENT AND THE THREAD IMPLANTED DATE OF (B)(6) 2024 AND REMOVAL DATE (B)(6) 2024. ON 07/09/2024, HCP WAS CONTACTED DUE TO INCORRECT INFORMATION PROVIDED PREVIOUSLY WHICH THEY PROVIDED THE CORRECT INFORMATION. 1). PREVIOUS INFORMATION: DATE OF EVENT: (B)(6) 2024. DATE REPORTED TO THE SALES REPRESENTATIVE: 4/22/2024. IMPLANTED DATE:(B)(6) 2024. REMOVAL DATE: (B)(6) 2024. 2). CORRECT INFORMATION: DATE OF EVENT: (B)(6) 2024. DATE REPORTED TO THE SALES REPRESENTATIVE: A FEW DAYS AFTER THE EVENT. IMPLANTED DATE: (B)(6) 2024. REMOVAL DATE: (B)(6) 2024.

    Description of Event or Problem · 0

    (B)(6) 2024, HCP REPORTED TO THE SALES REPRESENTATIVE THAT THE PATIENT HAD ONE THREAD POKING OUT FROM INSIDE OF THE MOUTH. ACCORDING TO THE HCP, THREAD WAS REMOVED BY THE PATIENT AT HOME. PATIENT REPORTED INTENSE PAIN AT THE DISTAL END OF THE THREAD AND HEARING A "SNAP" SOUND WHEN MOVING. PATIENT ALSO REPORTED FEELING THE THREADS MIGRATE UNDER THE SKIN. AT THE HCP'S CLINIC, PATIENT PRESENTED WITH THREE THREADS POKING FROM UNDER THE SKIN, TWO FROM THE RIGHT SIDE OF THE FACE (NLF AND CHIN), AND ONE RIGHT ON THE PATIENT'S LEFT PYRIFORM AREA. HCP REMOVED TWO THREADS ON THE RIGHT SIDE. HCP ATTEMPTED TO REMOVE THE THIRD THREAD ON THE PATIENT'S LEFT SIDE BUT WAS UNSUCCESSFUL. (B)(6) 2024, HCP REPORTED THAT THE PATIENT IS FINE AND NO ADDITIONAL FOLLOW-UP WAS NEEDED. UPDATE: ON (B)(6) 2024, HCP WAS CONTACTED TO PROVIDE PICTURES OF THE PATIENT AND ADDITIONAL INFORMATION REGARDING THE IMPLANTED AND REMOVAL DATE OF THE THREADS. ON (B)(6) 2024, HCP PROVIDED PICTURES OF THE PATIENT AND THE THREAD IMPLANTED DATE OF (B)(6) 2024 AND REMOVAL DATE (B)(6) 2024. ON (B)(6) 2024, HCP WAS CONTACTED DUE TO INCORRECT INFORMATION PROVIDED PREVIOUSLY WHICH THEY PROVIDED THE CORRECT INFORMATION. 1). PREVIOUS INFORMATION: DATE OF EVENT: 4/12/2024 DATE REPORTED TO THE SALES REPRESENTATIVE: 4/22/2024 IMPLANTED DATE: (B)(6) 2024 REMOVAL DATE: (B)(6) 2024 2). CORRECT INFORMATION: DATE OF EVENT: 5/10/2024 DATE REPORTED TO THE SALES REPRESENTATIVE: A FEW DAYS AFTER THE EVENT. IMPLANTED DATE:(B)(6) 2024 REMOVAL DATE: (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783842 DEMEDIOX ABSORBABLE POLYDIOXANONE SURGICAL SUTURE NEW DEMETECH CORPORATION PX2X783090A16MB L107-22 10652927777489

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention