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

Lot Number U103-21

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

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 12/07/2021

Event Type  Injury  

Event Description

On (b)(6) 2022, hcp implanted several pdo threads during a training above patient's knees and above elbows on the back of the arms.On (b)(6) 2022, patient stated she started to feel extreme pain.According to the patient, she started to feel the thread end poking up the skin on several spots of her knees and elbows.The threads had migrated 2 to 3 inches down her knee joint and elbow joint.On (b)(6) 2022, hcp tried to remove the threads by using a scalpel.6 threads were removed.Patient stated she felt immediate relief along the area where the threads were.On (b)(6) 2022, patient stated she had another thread migrating down her elbow joint.Thread was removed on the same day by using phlebectomy hooks.On (b)(6) 2022, patient stated she felt pain and a ripping sensation.According to the patient, she noticed a bruise forming.On (b)(6) 2022, hcp contacted the trainer who recommended injection of hylenex or kenalogg.Hcp decided to use ultherapy and rf microneedling instead.On (b)(6) 2022, hcp confirmed patient was much better, only with a slight discomfort on her arm.

• 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: 16414687
• MDR Text Key: 309948359
• Report Number: 3007895168-2022-00035
• 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: Administrator/Supervisor
• 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 Lot Number: U103-21
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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: 55 YR
• Patient Weight: 62 KG