BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMEDIOX

    MDR report key: 19515532 · Received June 11, 2024

    Report

    Report Number
    3007895168-2024-00009
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    June 6, 2024
    Report Date
    June 10, 2024
    Manufacturer
    DEMETECH CORPORATION
    Product Code
    NEW
    UDI-DI
    10652927721314
    PMA / PMN Number
    K082097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 3007895168-2024-00009 BRAND NAME: (B)(6), VERSION OR MODEL: PX2X29800100A16MB COMPANY NAME: (B)(6) PRIMARY DI NUMBER:(B)(4) DEVICE DESCRIPTION: ABSORBABLE POLYDIOXANONE SURGICAL SUTURE FDA PREMARKET SUBMISSION NUMBER: K082097.

    Description of Event or Problem · 0

    ON JUNE 6TH, 2024, HCP REPORTED TO THE SALES REPRESENTATIVE THAT A PATIENT HAD PDO THREADS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024 ACCORDING TO THE HCP, PATIENT EXPERIENCED THREADS DISLODGING AT ANCHOR AND THREAD POKING FROM UNDER THE SKIN AT THE ENDPOINT. DURING THE FOLLOW UP, HCP REMOVED THE THREAD AND A NEW THREAD WAS PLACED. ON JUNE 10TH, 2024, HCP REPORTED THAT THE PATIENT IS FINE.

    Description of Event or Problem · 0

    (B)(6) 2024, HCP REPORTED TO THE SALES REPRESENTATIVE THAT A PATIENT HAD PDO THREADS IMPLANTED ON (B)(6) 2024. (B)(6) 2024 ACCORDING TO THE HCP, PATIENT EXPERIENCED THREADS DISLODGING AT ANCHOR AND THREAD POKING FROM UNDER THE SKIN AT THE ENDPOINT. DURING THE FOLLOW UP, HCP REMOVED THE THREAD AND A NEW THREAD WAS PLACED. ON (B)(6) 2024, HCP REPORTED THAT THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208832 DEMEDIOX ABSORBABLE POLYDIOXANONE SURGICAL SUTURE NEW DEMETECH CORPORATION PX2X29800100A16MB S408-23 10652927721314

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention LASER, DYSPORT, HAIR RESTORATION WITH EXOSOMES.| LASER, DYSPORT, HAIR RESTORATION WITH EXOSOMES.