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

Lot Number G133-22

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

Patient Problems Pain (1994); Rupture (2208); Discomfort (2330)

Event Date 06/22/2022

Event Type  Injury  

Event Description

Novathreads were implanted on 06/20/2022.Patient received six infinity threads in the lower portion of the face.On (b)(6) 2022 patient reached out to the hcp stating that the pdo threads were protruding out of her lip.After prescribing prednisone, patient stated that the thread felt like it was floating and moved closer to the surface of skin.Eventually, on (b)(6) 2022 patient pulled the thread out with tweezers as it fully surfaced.On (b)(6) 2022 practitioner confirmed no medical advice was necessary.Patient has been checked on frequently and is fully healed.

• Brand Name: NOVATHREADS
• Type of Device: PDO 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: 16409085
• MDR Text Key: 309891019
• Report Number: 3007895168-2022-00020
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2023

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 Lot Number: G133-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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): Other
• Patient Age: 36 YR
• Patient Sex: Female