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

Lot Number A289-22

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

Patient Problems Pain (1994); Discomfort (2330); Nodule (4551)

Event Date 04/12/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 patient reported multiple pdo threads " tearing or snapping" appx 3 weeks after placement and many threads coming to surface of skin 3month post-placement.She had a few threads protrude from the skin on their own she reported: after placing threads , within 1-2 weeks threads started to protrude on their own; provider offered multiple appointments to see the client in office the day she reported, she said that she couldn't come several days due to her work schedule, but according to provider she made her aware that their office would fit her in schedule any day she would come & recommended she be seen immediately.Patient had a thread slightly protruding from inside mouth and then manually extracted the thread herself, which provider advised against, and communicated she come to office immediately.She continued to say that more threads were coming out: the threads that were placed over 3 months ago.Patient is stable but went two months with significant discomfort.Patient was prescribed antibiotics as recommended.Provider followed up within a week of starting antibiotics, patient texted "ok", but about a month or so later patient requested to be compensated, she mentioned litigation,and it was communicated to her that the event would be reported.Complimentary services almost equivalent to the cost of threads were offered.Patient received botox free at a follow up, where provider didn't observe any threads protruding at that time, however she had small pimple to right corner of mouth.She now reports that she has worse sagging of her cheeks (which if her threads were all torn/came out: going back to at least baseline (pre-threads she had laxity present already).Provider has pictures of her face the day threads were placed, and they look good.Nothing looked placed superficial or too deep.Patient is unhappy overall even with all the complimentary services offered, client declined & said "it wasn't enough".Provider didn't respond to our offer of medical advice.Provider sent last patient status on (b)(6) 2022.Several contact attempts were performed to gather additional information until (b)(6) 2022 without success.

• 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 33129 ; 3055380110
• MDR Report Key: 16376159
• MDR Text Key: 309554350
• Report Number: 3007895168-2022-00027
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: A289-22
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 51 YR
• Patient Sex: Female