BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMEDIOX

    MDR report key: 18768824 · Received February 23, 2024

    Report

    Report Number
    3007895168-2024-00004
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    December 28, 2023
    Report Date
    January 25, 2024
    Manufacturer
    DEMETECH CORPORATION
    Product Code
    NEW
    UDI-DI
    10652927777489
    PMA / PMN Number
    K082097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 3007895168-2024-00004. 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

    (B)(6) 2024, HCP REPORTED THAT A PATIENT HAD PDO THREADS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE HCP, PATIENT EXPERIENCED THREAD POKING UNDER THE SKIN AT THE ENDPOINT. (B)(6) 2024, PATIENT VISITED HCP FOR FOLLOW-UP AS TWO THREADS WERE BROKEN AND MIGRATED TO THE LIP. TWO PIECES OF THE BROKEN THREADS WERE REMOVED. (B)(6) 2024, PATIENT HAD ANOTHER FOLLOW UP WITH THE HCP WHERE TWO ADDITIONAL BROKEN THREADS WERE REPORTED. ONE THREAD MIGRATED TO THE CHIN AND WAS NOT REMOVED WHILE ONE BROKEN THREAD WAS REMOVED FROM THE LIP AREA. POST CARE TREATMENT RECOMMENDATIONS INCLUDED NOT TO DO ACTIVE SPORT AND FACE MOVEMENTS. MEDICAL ADVICE FROM THE MEDICAL DIRECTOR WAS OFFERED BUT THE HCP DECLINED. (B)(6) 2024, AFTER CONDUCTING A FOLLOW UP CONTACT WITH THE PRACTICE MANAGER, IT WAS CONFIRMED THAT THE PATIENT IS IN GOOD CONDITION.

    Description of Event or Problem · 0

    JANUARY 25TH 2024, HCP REPORTED THAT A PATIENT HAD PDO THREADS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE HCP, PATIENT EXPERIENCED THREAD POKING UNDER THE SKIN AT THE ENDPOINT. (B)(6) 2024, PATIENT VISITED HCP FOR FOLLOW-UP AS TWO THREADS WERE BROKEN AND MIGRATED TO THE LIP. TWO PIECES OF THE BROKEN THREADS WERE REMOVED. (B)(6) 2024, PATIENT HAD ANOTHER FOLLOW UP WITH THE HCP WHERE TWO ADDITIONAL BROKEN THREADS WERE REPORTED. ONE THREAD MIGRATED TO THE CHIN AND WAS NOT REMOVED WHILE ONE BROKEN THREAD WAS REMOVED FROM THE LIP AREA. POST CARE TREATMENT RECOMMENDATIONS INCLUDED NOT TO DO ACTIVE SPORT AND FACE MOVEMENTS. MEDICAL ADVICE FROM THE MEDICAL DIRECTOR WAS OFFERED BUT THE HCP DECLINED. (B)(6) 2024, AFTER CONDUCTING A FOLLOW UP CONTACT WITH THE PRACTICE MANAGER, IT WAS CONFIRMED THAT THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128960 DEMEDIOX ABSORBABLE POLYDIOXANONE SURGICAL SUTURE NEW DEMETECH CORPORATION PX2X783090A16MB J217-22 10652927777489

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention