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

Model Number	PX2X29800100A16MB
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the customer reported to the sales representative that the patient had pdo threads coming out from the insertion site.Hcp requested medical advice from the medical director which they were provided.The medical director suggested that the threads need to be pulled out and the patient needs to be placed on antibiotics.On 07/03/2024, according to the hcp, threads needed to be pulled out to be able to extract the threads.Hcp stated that the threads were extracted on (b)(6) 2024.Hcp also reported that the patient had pdo threads implanted 48 hours ((b)(6) 2024) before the removal date of (b)(6) 2024.On 07/03/2024, hcp stated that the patient is fine and does not require antibiotics.
Additional Manufacturer Narrative
Udi related data quality updates only the report represents a correction to a previously submitted mdr 3007895168-2024-00013.Brand name: demediox.Version or model: px2x29800100a16mb.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 customer reported to the sales representative that the patient had pdo threads coming out from the insertion site.Hcp requested medical advice from the medical director which they were provided.The medical director suggested that the threads need to be pulled out and the patient needs to be placed on antibiotics.On (b)(6) 2024, according to the hcp, threads needed to be pulled out to be able to extract the threads.Hcp stated that the threads were extracted on (b)(6) 2024.Hcp also reported that the patient had pdo threads implanted 48 hours ((b)(6) 2024) before the removal date of (b)(6) 2024.On (b)(6) 2024, hcp stated that the patient is fine and does not require antibiotics.

• 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: 19671182
• Report Number: 3007895168-2024-00013
• Device Sequence Number: 15162394
• Product Code: NEW
• UDI-Device Identifier: 10652927721314
• UDI-Public: 10652927721314
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 09/01/2026
• Device Model Number: PX2X29800100A16MB
• Device Lot Number: S408-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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: Unknown