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

Lot Number DW1C-4DA2160190313

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Nausea (1970); Dizziness (2194); Neuralgia (4413)

Event Date 09/13/2019

Event Type  Injury  

Event Description

On 01/24/2020, hcp reports patient had pdo threads implanted on (b)(6) 2019 and sends statements mentioning the patient was having severe pain in her face, plugged ears, dizziness, nauseas and tightness in nose and head.According to patient statement, the pain started a day after pdo threads were implanted.Patient visited a neurologist who diagnosed her with trigeminal neuralgia caused by the threads.Physician mentioned it could be permanent but should be temporary because patient still had feeling in her face.A second statement mentioned her doctor said the trigeminal nerve runs in the same direction and place that the threads were inserted, but it could also be the multiple lidocaine injections made in the same area.She does not think the trigeminal nerve could have been hit as it lies too deep, but rather the branches that come out of it.Hcp used two types of pdo threads, one of the products was confirmed to be expired by the time of treatment.On 01/27/2020, our medical director mentioned this issue could not conceivably be related to the threads and offered the provider to discuss the situation further.However, no additional updates have been indicated.

• 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: 16414331
• MDR Text Key: 309948481
• Report Number: 3007895168-2022-00030
• 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: 03/24/2020
• Device Lot Number: DW1C-4DA2160190313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2020
• 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
• Treatment: REFLEX 500MG
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female