BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMEDIOX

    MDR report key: 19671182 · Received July 3, 2024

    Report

    Report Number
    3007895168-2024-00013
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 26, 2024
    Report Date
    June 26, 2024
    Manufacturer
    DEMETECH CORPORATION
    Product Code
    NEW
    UDI-DI
    10652927721314
    PMA / PMN Number
    K082097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 3007895168-2024-00013. BRAND NAME: DEMEDIOX. VERSION OR MODEL: PX2X29800100A16MB. 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 CUSTOMER REPORTED TO THE SALES REPRESENTATIVE THAT THE PATIENT HAD PDO THREADS COMING OUT FROM THE INSERTION SITE. HCP REQUESTED MEDICAL ADVICE FROM THE MEDICAL DIRECTOR WHICH THEY WERE PROVIDED. THE MEDICAL DIRECTOR SUGGESTED THAT THE THREADS NEED TO BE PULLED OUT AND THE PATIENT NEEDS TO BE PLACED ON ANTIBIOTICS. ON 07/03/2024, ACCORDING TO THE HCP, THREADS NEEDED TO BE PULLED OUT TO BE ABLE TO EXTRACT THE THREADS. HCP STATED THAT THE THREADS WERE EXTRACTED ON (B)(6) 2024. HCP ALSO REPORTED THAT THE PATIENT HAD PDO THREADS IMPLANTED 48 HOURS ((B)(6) 2024) BEFORE THE REMOVAL DATE OF (B)(6) 2024. ON 07/03/2024, HCP STATED THAT THE PATIENT IS FINE AND DOES NOT REQUIRE ANTIBIOTICS.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE CUSTOMER REPORTED TO THE SALES REPRESENTATIVE THAT THE PATIENT HAD PDO THREADS COMING OUT FROM THE INSERTION SITE. HCP REQUESTED MEDICAL ADVICE FROM THE MEDICAL DIRECTOR WHICH THEY WERE PROVIDED. THE MEDICAL DIRECTOR SUGGESTED THAT THE THREADS NEED TO BE PULLED OUT AND THE PATIENT NEEDS TO BE PLACED ON ANTIBIOTICS. ON (B)(6) 2024, ACCORDING TO THE HCP, THREADS NEEDED TO BE PULLED OUT TO BE ABLE TO EXTRACT THE THREADS. HCP STATED THAT THE THREADS WERE EXTRACTED ON (B)(6) 2024. HCP ALSO REPORTED THAT THE PATIENT HAD PDO THREADS IMPLANTED 48 HOURS ((B)(6) 2024) BEFORE THE REMOVAL DATE OF (B)(6) 2024. ON (B)(6) 2024, HCP STATED THAT THE PATIENT IS FINE AND DOES NOT REQUIRE ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446801 DEMEDIOX ABSORBABLE POLYDIOXANONE SURGICAL SUTURE NEW DEMETECH CORPORATION PX2X29800100A16MB S408-23 10652927721314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention