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

Model Number	PX2X783090A16MB
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
January 25th 2024, hcp reported that a patient had pdo threads implanted on (b)(6) 2023.According to the hcp, patient experienced thread poking under the skin at the endpoint.(b)(6) 2024, patient visited hcp for follow-up as two threads were broken and migrated to the lip.Two pieces of the broken threads were removed.(b)(6) 2024, patient had another follow up with the hcp where two additional broken threads were reported.One thread migrated to the chin and was not removed while one broken thread was removed from the lip area.Post care treatment recommendations included not to do active sport and face movements.Medical advice from the medical director was offered but the hcp declined.(b)(6) 2024, after conducting a follow up contact with the practice manager, it was confirmed that the patient is in good condition.
Event or Problem Description
(b)(6) 2024, hcp reported that a patient had pdo threads implanted on (b)(6) 2023.According to the hcp, patient experienced thread poking under the skin at the endpoint.(b)(6) 2024, patient visited hcp for follow-up as two threads were broken and migrated to the lip.Two pieces of the broken threads were removed.(b)(6) 2024, patient had another follow up with the hcp where two additional broken threads were reported.One thread migrated to the chin and was not removed while one broken thread was removed from the lip area.Post care treatment recommendations included not to do active sport and face movements.Medical advice from the medical director was offered but the hcp declined.(b)(6) 2024, after conducting a follow up contact with the practice manager, it was confirmed that the patient is in good condition.
Additional Manufacturer Narrative
Udi related data quality updates only.The report represents a correction to a previously submitted mdr 3007895168-2024-00004.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.

• 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: 18768824
• Report Number: 3007895168-2024-00004
• Device Sequence Number: 15388258
• Product Code: NEW
• UDI-Device Identifier: 10652927777489
• UDI-Public: 10652927777489
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: 05/01/2025
• Device Model Number: PX2X783090A16MB
• Device Lot Number: J217-22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 11/29/2024
• Date Device Manufactured: 05/01/2022
• 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 Age: 54 YR
• Patient Sex: Female