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

Lot Number DW1C-MDA18100200711

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

Patient Problem Pain (1994)

Event Date 10/13/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, hcp implanted 10 pdo threads in mid-face and lower face.At time of treatment, no buckles or protrusions were observed.On (b)(6) 2020, patient called the practitioner and stated she was in pain around her chin and had a divot on her right cheek.According to the physician, both appeared to be related to one thread that may have slipped.On (b)(6) 2020, hcp made a subcision with a 27g cannula and agreed to a follow up visit with the patient on (b)(6) 2020.On (b)(6) 2020, our medical director made attempts to get in touch with the provider.On 10/21/2020, hcp confirmed patient was doing fine.

• 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: 16414401
• MDR Text Key: 309948704
• Report Number: 3007895168-2022-00031
• 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
• Type of Report: Initial
• Report Date: 02/13/2023

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: 07/26/2021
• Device Lot Number: DW1C-MDA18100200711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 64 KG