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

Lot Number AKB170986

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Unspecified Infection (1930); Swelling (2091)

Event Date 04/23/2018

Event Type  Injury  

Event Description

Novathread was implanted on (b)(6) 2020 and patient had one week post op follow up and was doing fine.On (b)(6) 2020 patient noticed soft tissue swelling on her right tear through and righ cheek.Patient was examined and soft tissue swelling was noticed but no obvious signs of infection.Patient said, swelling resolved on it own, but then 2-3 weeks later the patient showed up with a pustule in the middle of her right nasal labial fold and her right cheek was obviously swollen and hard to palpate.The pustule was drained.Patient was placed on bactrim for two weeks, and asked to do warm compress at home.The lesion and the infection resolved; her right cheek felt slightly hard along the thread line.She was without antibiotics for 3-4 days and then the pustule came back.Patient was seen on same day she went to kaiser er where a culture was taken and she was put on antibiotics for 2 weeks and the culture did not grow any organisms.There was no sign of infection for the first 6 weeks.The pustule location is either the insertion area or the anchor spot.Patient goes swimming daily in a (b)(6) pool and only put off swimming for 4-5 days post op.

• Brand Name: NOVATHREADS
• Type of Device: PDO BARBED SUTURE
• Manufacturer (Section D): ECTODERMA DBA COSMOFRANCE; 1444 biscayne blvd; suite 218; miami FL 33132 1422
• Manufacturer Contact: samantha seldin ; 1444 biscayne blvd; suite 218; miami, FL 33132 ; 3055380110
• MDR Report Key: 10521815
• MDR Text Key: 206550007
• Report Number: 3007895168-2020-00002
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: AKB170986
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 09/11/2020
• 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): Other