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

Lot Number DW1C-4DA18100220710

Device Problems Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2022

Event Type  Injury  

Event Description

Novathreads pdo barbed threads were implanted on (b)(6) 2022.3 weeks post treatment, thread broke and migrated through the skin.Thread was removed.(b)(6) 2022, practitioner confirmed that the patient was doing well after threads were removed without issues.

• Brand Name: NOVATHREADS
• Type of Device: PDO BARBED SUTURE
• Manufacturer (Section D): ECTODERMA DBA COSMOFRANCE; 2121 sw 3rd ave; suite 500; miami FL 33129
• Manufacturer Contact: 2121 sw 3rd ave; suite 500; miami, FL 33129 ; 3055380110
• MDR Report Key: 16411035
• MDR Text Key: 309946748
• Report Number: 3007895168-2022-00013
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2023
• Device Lot Number: DW1C-4DA18100220710
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 64 KG