MAUDE Adverse Event Report: ECTODERMA DBA COSMOFRANCE NOVATHREADS; PDO SUTURE

Lot Number J217-22

Device Problems Break (1069); Material Fragmentation (1261); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem Nodule (4551)

Event Date 12/28/2023

Event Type  Injury  

Event 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.

• Brand Name: NOVATHREADS
• Type of Device: PDO SUTURE
• Manufacturer (Section D): ECTODERMA DBA COSMOFRANCE; 2121 sw 3rd ave ste 500; miami FL 33129
• Manufacturer (Section G): ECTODERMA DBA COSMOFRANCE; 2121 sw 3rd ave ste 500; miami FL 33129
• MDR Report Key: 18768824
• MDR Text Key: 336123747
• Report Number: 3007895168-2024-00004
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: J217-22
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2024
• Date Device Manufactured: 05/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female