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

Lot Number DW1C-4DA18100211127

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 02/26/2022

Event Type  Injury  

Event Description

Novathreads pdo barbed threads were inserted on (b)(6)2022.(b)(6) 2022 first follow up - patient expressed her face hurt.Practitioner started a radiofrequency treatment to dissolve the pdo threads.(b)(6) 2022 practitioner contacted novathreads to report the possible adverse event as the patient keeps having major pain and mentioned she could still feel the threads on her face.Doctor mentioned she didn't have appointments scheduled with the patient as she did everything, she could to dissolve the threads.Practitioner requested advice from the medical director (b)(6) 2022 patient contacted novathreads several times explaining she was very upset about her face and needed an answer urgently.(b)(6) 2022 medical director explained it's highly unusual for a patient to be in pain 10 months post-treatment as the threads would be mostly metabolized even if it was placed too deep, which could be the case if the patient had pain since the beginning of the treatment.Therefore, practitioner should refer patient to a facial pain specialist as there is likely something else going on.Medical director also recommended the practitioner to report this sooner as if threads were placed too deep, they could have potentially been retrieved / removed in the first 1-2 months, but now it would not be advisable to try to retrieve.(b)(6 )2022 various contacts attempts were made to the doctor after medical advice was provided to follow up on the patient condition.(b)(6) 2022 the practitioner confirmed the patient was still in pain.(b)(6) 2023 multiple additional attempts have been made to verify actions taken without a response from the physician.

Event Description

Novathreads pdo barbed threads were inserted on (b)(6) 2022.On (b)(6) 2022, first follow up, patient expressed her face hurt.Practitioner started a radiofrequency treatment to dissolve the pdo threads.On (b)(6) 2022, practitioner contacted novathreads to report the possible adverse event as the patient keeps having major pain and mentioned she could still feel the threads on her face.Doctor mentioned she didn't have appointments scheduled with the patient as she did everything, she could to dissolve the threads.Practitioner requested advice from the medical director on (b)(6) 2022, patient contacted novathreads several times explaining she was very upset about her face and needed an answer urgently.On (b)(6) 2022, medical director explained it's highly unusual for a patient to be in pain 10 months post-treatment as the threads would be mostly metabolized even if it was placed too deep, which could be the case if the patient had pain since the beginning of the treatment.Therefore, practitioner should refer patient to a facial pain specialist as there is likely something else going on.Medical director also recommended the practitioner to report this sooner as if threads were placed too deep, they could have potentially been retrieved / removed in the first 1-2 months, but now it would not be advisable to try to retrieve.On (b)(6) 2022, various contacts attempts were made to the doctor after medical advice was provided to follow up on the patient condition.On (b)(6) 2022, the practitioner confirmed the patient was still in pain.On (b)(6) 2023, multiple additional attempts have been made to verify actions taken without a response from the physician.Update: on may 3, 2023, hcp confirmed multiple attempts have been made to contact the patient and no response was received.As a result, the hcp cautiously believes that the patient's current condition is stable.

• Brand Name: NOVATHREADS
• Type of Device: PDO BARBED THREADS
• 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: 16410541
• MDR Text Key: 309922804
• Report Number: 3007895168-2022-00015
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: 11/11/2022
• Device Lot Number: DW1C-4DA18100211127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• 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): Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 68 KG