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

Model Number	PX2X29800100A16MB
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) 2024, hcp reported to the sales representative that a patient had pdo threads implanted on (b)(6) 2024.(b)(6) 2024 according to the hcp, patient experienced threads dislodging at anchor and thread poking from under the skin at the endpoint.During the follow up, hcp removed the thread and a new thread was placed.On (b)(6) 2024, hcp reported that the patient is fine.
Event or Problem Description
On june 6th, 2024, hcp reported to the sales representative that a patient had pdo threads implanted on (b)(6) 2024.On (b)(6) 2024 according to the hcp, patient experienced threads dislodging at anchor and thread poking from under the skin at the endpoint.During the follow up, hcp removed the thread and a new thread was placed.On june 10th, 2024, hcp reported that the patient is fine.
Additional Manufacturer Narrative
Udi related data quality updates only the report represents a correction to a previously submitted mdr 3007895168-2024-00009 brand name: (b)(6), version or model: px2x29800100a16mb company name: (b)(6) 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: 19515532
• Report Number: 3007895168-2024-00009
• Device Sequence Number: 7392575
• Product Code: NEW
• UDI-Device Identifier: 10652927721314
• UDI-Public: 10652927721314
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/10/2024

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: 06/10/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LASER, DYSPORT, HAIR RESTORATION WITH EXOSOMES.; LASER, DYSPORT, HAIR RESTORATION WITH EXOSOMES.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female