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

Model Number	PX2X783090A16MB
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Discomfort (2330); Nodule (4551)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2024, the patient reported that they had pdo threads implanted on (b)(6) 2024.On (b)(6), 2024, according to the hcp, patient experienced pain with the thread poking under the skin at the endpoint in the middle of the neck.During the follow-up, patient was injected with hyaluronic acid by the hcp to soften the thread.According to the hcp, patient presented no changes two weeks later.Patient experienced another pdo thread migrated from the jawline into the chin.Hcp extracted the thread and attempted to remove another thread at the thyroid cartilage aspect but was unsuccessful.Patient was injected with hyaluronic acid by the hcp again to soften the thread.On (b)(6), 2024, hcp was informed by the patient that the thread had extruded out.On (b)(6), 2024, the hcp confirmed that the patient is currently in good condition.
Additional Manufacturer Narrative
Udi related data quality updates only.The report represents a correction to a previously submitted mdr 3007895168-2024-00007.Brand name: demediox.Version or model: px2x783090a16mb.Company name: demetech corporation.Primary di number: (b)(4).Device description: absorbable polydioxanone surgical suture.Fda premarket submission number: k082097.
Event or Problem Description
On (b)(6) 2024, the patient reported that they had pdo threads implanted on (b)(6) 2024.On (b)(6) 2024, according to the hcp, patient experienced pain with the thread poking under the skin at the endpoint in the middle of the neck.During the follow-up, patient was injected with hyaluronic acid by the hcp to soften the thread.According to the hcp, patient presented no changes two weeks later.Patient experienced another pdo thread migrated from the jawline into the chin.Hcp extracted the thread and attempted to remove another thread at the thyroid cartilage aspect but was unsuccessful.Patient was injected with hyaluronic acid by the hcp again to soften the thread.On (b)(6) 2024, hcp was informed by the patient that the thread had extruded out.On (b)(6) 2024, the hcp confirmed that the patient is currently in good condition.

• 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: 19281936
• Report Number: 3007895168-2024-00007
• Device Sequence Number: 15351509
• Product Code: NEW
• UDI-Device Identifier: 10652927777489
• UDI-Public: 10652927777489
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: 06/01/2025
• Device Model Number: PX2X783090A16MB
• Device Lot Number: L107-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 01/24/2025
• Date Device Manufactured: 06/01/2022
• 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: Required Intervention
• Patient Sex: Female