MAUDE Adverse Event Report: DONGWON MEDICAL CO.,LTD DW-1C; ABSORBABLE POLYDIOXANONE SURGICAL SUTURE

Model Number	DWFA-1C
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Granuloma (1876); Nodule (4551)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Event or Problem Description
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.

• Brand Name: DW-1C
• Common Device Name: ABSORBABLE POLYDIOXANONE SURGICAL SUTURE
• Manufacturer (Section D): DONGWON MEDICAL CO.,LTD; gwangju, gwangsan-gu ; KS
• Manufacturer (Section G): ECTODERMA DBA COSMOFRANCE; 2121 sw 3rd ave ste 500; miami FL 33129
• MDR Report Key: 23865697
• Report Number: 3007895168-2025-00004
• Device Sequence Number: 5343807
• Product Code: NEW
• UDI-Device Identifier: 08800050100000
• UDI-Public: 08800050100000
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2026
• Device Model Number: DWFA-1C
• Device Lot Number: DW1C-4DA18100250504
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 05/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female