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	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, hcp reported that the patient experienced thread protrusion 1 week after insertion.An email was sent to the hcp to gather additional information.On (b)(6) 2025, a phone call was made to the hcp to gather additional information with no response.Another follow-up email was sent to the hcp with no response.On (b)(6) 2025, a 2nd follow-up email was sent to the hcp.On (b)(6) 2025, hcp replied to the email providing the information requested.Hcp reported that the pdo threads were implanted on (b)(6) 2024 and were extracted on (b)(6) 2025.According to the hcp, the patient's skin has healed as per the patient's follow up visit on (b)(6) 2025.Hcp has stated the patient has another area of concern that will need a follow-up and has requested medical advice from the medical director.On (b)(6) 2025, medical advice was provided by the medical director which will be forwarded to the hcp.This is an ongoing investigation.Additional information will be provided if and when it is available.
Event or Problem Description
On (b)(6) 2025, hcp reported that the patient experienced thread protrusion 1 week after insertion.An email was sent to the hcp to gather additional information.On (b)(6) 2025, a phone call was made to the hcp to gather additional information with no response.Another follow-up email was sent to the hcp with no response.On (b)(6) 2025, a 2nd follow-up email was sent to the hcp.On (b)(6) 2025, hcp replied to the email providing the information requested.Hcp reported that the pdo threads were implanted on (b)(6)2024 and were extracted on (b)(6)2025.According to the hcp, the patient's skin has healed as per the patient's follow up visit on (b)(6) 2025.Hcp has stated the patient has another area of concern that will need a follow-up and has requested medical advice from the medical director.On (b)(6) 2025, medical advice was provided by the medical director which will be forwarded to the hcp.This is an ongoing investigation.Additional information will be provided if and when it is available.Update: on (b)(6) 2025, the hcp had requested additional information for training which they were guided to contact the sales representative.On (b)(6) 2025, a follow-up email was sent to the hcp to inquire about the status of the patient.On (b)(6), 2025, a phone call was made to the hcp to inquire about the status of the patient.On (b)(6) 2025, the hcp returned the phone call and stated that the patient was doing perfectly fine and that no further follow-up would be needed.Hcp has been informed that the case is now 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: 21292327
• Report Number: 3007895168-2025-00001
• Device Sequence Number: 18079263
• Product Code: NEW
• UDI-Device Identifier: 10652927721314
• UDI-Public: 10652927721314
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: PX2X29800100A16MB
• Device Lot Number: E147-24
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/25/2025
• 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: 73 YR
• Patient Sex: Female