MAUDE Adverse Event Report: DEMETECH CORPORATION DEMEDIOX; ABSORBABLE POLYDIOXANONE SURGICAL SUTURE

Model Number	PX2X45800100A16MTB
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On august 5th, 2025, hcp reported placing pdo threads on (b)(6) 2025.According to the hcp, on (b)(6) 2025, the patient experienced thread migration and protrusion appearing like a vein on the forehead pushing on a nerve with tenderness to touch.The hcp stated that there was a total placement of 5 threads on one side and 4 threads on the other.Medical advice was requested by the hcp.An email was sent to the hcp to gather additional information.A secondary email was sent to the medical director for medical advice.On (b)(6) 2025, medical advice was provided from the medical director which was forwarded to the hcp.The medical director advised that the pain is probably from skin or muscle and not a nerve.The medical director recommended thread removal if the patient is troubled by appearance.On august 20th, 2025, an email was sent to the hcp to inquire about the status of the patient and to confirm if any threads were extracted.On september 3rd, a phone call was made to the hcp to gather information on the status of the patient and to confirm if any threads were extracted.The point of contact at the hcp was not available.Another follow up email was sent to the hcp.On september 4th, 2025, hcp replied back to the email stating that the threads will not be extracted from the patient and will give it more time.Hcp confirmed that the patient is no longer experiencing pain.On september 5th, 2025, hcp has been informed that the case is now closed.

• Brand Name: DEMEDIOX
• Common Device Name: ABSORBABLE POLYDIOXANONE SURGICAL SUTURE
• Manufacturer (Section D): DEMETECH CORPORATION; 5980 miami lakes dr; miami lakes FL 33014
• Manufacturer (Section G): ECTODERMA DBA COSMOFRANCE; 2121 sw 3rd ave ste 500; miami FL 33129
• MDR Report Key: 23016282
• Report Number: 3007895168-2025-00002
• Device Sequence Number: 15908916
• Product Code: NEW
• UDI-Device Identifier: 10652927784418
• UDI-Public: 10652927784418
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082097
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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 Model Number: PX2X45800100A16MTB
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 09/10/2025
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 68 KG