BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DW-1C

    MDR report key: 23865697 · Received December 22, 2025

    Report

    Report Number
    3007895168-2025-00004
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 28, 2025
    Report Date
    December 16, 2025
    Manufacturer
    DONGWON MEDICAL CO.,LTD
    Product Code
    NEW
    UDI-DI
    08800050100000
    PMA / PMN Number
    K160761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT DEVELOPED REDNESS WITH STREAKING AND SWELLING ALONG THE LEFT CHEEK APPROXIMATELY 10 DAYS POST-TREATMENT, FOLLOWING ACCIDENTAL CONTACT WITH THE TREATED AREA. THE PATIENT SUBSEQUENTLY DEVELOPED AN OPEN WOUND, AND DERMATOLOGY EXPRESSED CONCERN REGARDING ACTIVE BLEEDING. THE PATIENT HAS BEEN EVALUATED BY A NURSE PRACTITIONER (NP) AND A MEDICAL DOCTOR (MD) AND IS CURRENTLY ON A SECOND COURSE OF ANTIBIOTICS. THE HCP REQUESTED CONSULTATION WITH THE MEDICAL DIRECTOR FOR FURTHER CLINICAL GUIDANCE. ON DECEMBER 20, 2025, THE MEDICAL DIRECTOR SPOKE WITH THE HCP TO DISCUSS THE CASE AND PROVIDE GUIDANCE. PATIENT OUTCOME REMAINS PENDING AT THE TIME OF THIS REPORT. UPDATE WILL BE PROVIDED IF AND WHEN IT BECOMES AVAILABLE. UPDATE: ON JANUARY 5TH, 2026, A FOLLOW UP EMAIL WAS SENT TO THE SALES REPRESENTATIVE TO CHECK ON THE STATUS OF THE PATIENT. NO RESPONSE WAS RECEIVED. ON JANUARY 13TH, 2026, ANOTHER FOLLOW UP EMAIL WAS SENT TO CHECK ON THE STATUS OF THE PATIENT. THE SALES REPRESENTATIVE PROVIDED AN UPDATE FROM A TEXT EXCHANGE IN WHICH THE HCP REPORTED THAT THE PATIENT WAS SEEN BY DERMATOLOGIST AND DIAGNOSED WITH A GRANULOMA. THE DERMATOLOGIST INDICATED THE GRANULOMA WOULD LIKELY BE TREATED WITH INJECTABLE STEROIDS AFTER COMPLETION OF ANTIBIOTICS AND CONFIRMATION THAT INFECTION HAD RESOLVED. THE HCP DESCRIBED THE CASE AS UNUSUAL AND STATED AN INTENTION TO CONTACT THE MEDICAL DIRECTOR. ON JANUARY 28TH, 2026 , A THIRD FOLLOW-UP EMAIL WAS SENT REQUESTING ANY UPDATES. THE SALES REPRESENTATIVE REPLIED THAT NO NEW INFORMATION WAS AVAILABLE AND LATER CONFIRMED BY PHONE THAT THE HCP HAD SPOKEN DIRECTLY WITH THE MEDICAL DIRECTOR. NO ADDITIONAL PATIENT UPDATES WERE PROVIDED, AND THE COMPLAINT WAS CONSIDERED CLOSED. NO FURTHER INFORMATION IS AVAILABLE FROM THE REPORTER AT THIS TIME.

    Description of Event or Problem · 0

    ON DECEMBER 16, 2025, THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT DEVELOPED REDNESS WITH STREAKING AND SWELLING ALONG THE LEFT CHEEK APPROXIMATELY 10 DAYS POST-TREATMENT, FOLLOWING ACCIDENTAL CONTACT WITH THE TREATED AREA. THE PATIENT SUBSEQUENTLY DEVELOPED AN OPEN WOUND, AND DERMATOLOGY EXPRESSED CONCERN REGARDING ACTIVE BLEEDING. THE PATIENT HAS BEEN EVALUATED BY A NURSE PRACTITIONER (NP) AND A MEDICAL DOCTOR (MD) AND IS CURRENTLY ON A SECOND COURSE OF ANTIBIOTICS. THE HCP REQUESTED CONSULTATION WITH THE MEDICAL DIRECTOR FOR FURTHER CLINICAL GUIDANCE. ON DECEMBER 20, 2025, THE MEDICAL DIRECTOR SPOKE WITH THE HCP TO DISCUSS THE CASE AND PROVIDE GUIDANCE. PATIENT OUTCOME REMAINS PENDING AT THE TIME OF THIS REPORT. UPDATE WILL BE PROVIDED IF AND WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390393 DW-1C ABSORBABLE POLYDIOXANONE SURGICAL SUTURE NEW DONGWON MEDICAL CO.,LTD DWFA-1C DW1C-4DA18100250504 08800050100000

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other