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

Model Number	PX2X45800100A16MTB
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Numbness (2415); Nodule (4551)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, hcp reported to the sales representative that a pdo thread was implanted on the patient's cheek.According to the hcp, the patient experienced a pop after eating on the left side and now has a little numbness and a little bump formed in the marionette area.Hcp also reported that they tried to remove the thread from the skin by using a cannula and undermining the tissue, but it was not moving.On september 8th, 2024, the sales representative had asked the hcp for pictures of the patient.On september 9th, 2024, hcp provided the pictures that were requested.A request was made to the medical director to obtain medical advice on the case.On september 10th, 2024, the medical director provided medical advice which was forwarded to the hcp.On october 1st, 2024, follow up email was made to the hcp to inquire about the status of the patient.On october 4th, 2024, follow up communication was made to the sales representative to inquire about the status of the patient from the hcp.On october 7th, 2024, another follow up email was sent to the hcp to inquire about the status of the patient.Hcp replied that the patient is doing better.According to the hcp, they were able to cut the end of the thread which was folded over two weeks ago.Hcp stated that the thread had moved again and there was no visible bump on the patient.Hcp also reported that the patient's skin is bunch a little bit where the thread shifted.On october 7th, 2024, follow up email was made to the hcp to inquire if there would be a follow-up between the hcp and the patient.On october 17th, 2024, another follow up email was made to the hcp to inquire if there would be a follow-up between the hcp and the patient.Hcp replied that there will be a follow-up.On october 17th, 2024, email was sent to the hcp to find out additional information and to notify that a follow up on the patient status will be conducted in the next few weeks.This is an ongoing investigation.Additional information will be provided if and when it is available.
Event or Problem Description
On september 6th, 2024, hcp reported to the sales representative that a pdo thread was implanted on the patient's cheek.According to the hcp, the patient experienced a pop after eating on the left side and now has a little numbness and a little bump formed in the marionette area.Hcp also reported that they tried to remove the thread from the skin by using a cannula and undermining the tissue, but it was not moving.On (b)(6) 2024, the sales representative had asked the hcp for pictures of the patient.On (b)(6) 2024, hcp provided the pictures that were requested.A request was made to the medical director to obtain medical advice on the case.On (b)(6) 2024, the medical director provided medical advice which was forwarded to the hcp.On (b)(6) 2024, follow up email was made to the hcp to inquire about the status of the patient.On october 4th, 2024, follow up communication was made to the sales representative to inquire about the status of the patient from the hcp.On (b)(6) 2024, another follow up email was sent to the hcp to inquire about the status of the patient.Hcp replied that the patient is doing better.According to the hcp, they were able to cut the end of the thread which was folded over two weeks ago.Hcp stated that the thread had moved again and there was no visible bump on the patient.Hcp also reported that the patient's skin is bunch a little bit where the thread shifted.On (b)(6) 2024, follow up email was made to the hcp to inquire if there would be a follow-up between the hcp and the patient.On (b)(6) 2024, another follow up email was made to the hcp to inquire if there would be a follow-up between the hcp and the patient.Hcp replied that there will be a follow-up.On october 17th, 2024, email was sent to the hcp to find out additional information and to notify that a follow up on the patient status will be conducted in the next few weeks.This is an ongoing investigation.Additional information will be provided if and when it is available.Update: on (b)(6) 2024, a follow up email was sent to the hcp to gather additional information and the status of the patient.Hcp did not reply to the email.On (b)(6) 2024, another follow up email was sent to the hcp to gather the additional information.On (b)(6) 2024, a call was made to the sales representative to assist in contacting the hcp.On (b)(6) 2024, a third follow up email was sent to the hcp with no response.On (b)(6) 2024, a fourth follow up email was sent to the hcp.Hcp replied with the same information that was previously stated on (b)(6) 2024.According to the hcp, the patient is fine.

• 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: 20500918
• Report Number: 3007895168-2024-00016
• Device Sequence Number: 7245345
• Product Code: NEW
• UDI-Device Identifier: 10652927784418
• UDI-Public: 10652927784418
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K082097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/09/2024

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 Model Number: PX2X45800100A16MTB
• Device Lot Number: C321-24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/13/2024
• 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: Female