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

Model Number	PX2X46800100A16B
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a healthcare provider (hcp) reported that a patient presented with palpable pdo barb threads beneath the skin along the right mandible.The threads were not externally visible.The hcp noted a localized elevation at the site with no erythema, drainage, or tenderness observed.The hcp attempted to access the area using an 18g needle to remove or trim the threads; however, the removal attempt was unsuccessful.The hcp requested medical guidance.On november 10, 2025, the medical director provided instructions to utilize the threadmate tool and supplied thread-removal instructional materials.On december 8, 2025, a follow-up was conducted to obtain updated information regarding the patient and to determine whether thread removal was successful.The hcp reported that they were unable to visualize the threads and that removal attempts remained unsuccessful.The hcp requested additional medical guidance.The medical director subsequently offered to evaluate the patient in person through a consultation.At the time of this report, no infection, drainage, or adverse systemic symptoms have been reported.Patient outcome remains unchanged, and medical evaluation is pending.Update will be provided if and when it becomes available.
Event or Problem Description
On (b)(6) 2025, a healthcare provider (hcp) reported that a patient presented with palpable pdo barb threads beneath the skin along the right mandible.The threads were not externally visible.The hcp noted a localized elevation at the site with no erythema, drainage, or tenderness observed.The hcp attempted to access the area using an 18g needle to remove or trim the threads; however, the removal attempt was unsuccessful.The hcp requested medical guidance.On (b)(6) 2025, the medical director provided instructions to utilize the threadmate tool and supplied thread-removal instructional materials.On (b)(6) 2025, a follow-up was conducted to obtain updated information regarding the patient and to determine whether thread removal was successful.The hcp reported that they were unable to visualize the threads and that removal attempts remained unsuccessful.The hcp requested additional medical guidance.The medical director subsequently offered to evaluate the patient in person through a consultation.At the time of this report, no infection, drainage, or adverse systemic symptoms have been reported.Patient outcome remains unchanged, and medical evaluation is pending.Update will be provided if and when it becomes available.Update: on january 5, 2026, a follow-up email was sent to the hcp requesting an update on the patient's condition and whether the pdo threads had been successfully removed.The hcp replied to the prior communication stating: "based on some anecdotal literature, we decided to inject hylenex, which worked, and the patient is happy." this case is confirmed to be 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: 23817668
• Report Number: 3007895168-2025-00003
• Device Sequence Number: 13085168
• Product Code: NEW
• UDI-Device Identifier: 10652927697879
• UDI-Public: 10652927697879
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: PX2X46800100A16B
• Device Lot Number: J191-24
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/12/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HYLENEX
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female