FDA Adverse Event
Injury
Summary report: N
NOVATHREADS
MDR report key: 17137891
·
Received June 15, 2023
Report
- Report Number
- 3007895168-2022-00046
- Event Type
- Injury
- Date Received
- June 15, 2023
- Date of Event
- January 27, 2022
- Report Date
- March 3, 2023
- Manufacturer
- ECTODERMA DBA COSMOFRANCE
- Product Code
- NEW
- PMA / PMN Number
- K191361
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 117
Narratives
Description of Event or Problem · 0
06/30/2022, HCP REPORTED A PATIENT THAT HAD MOLDED PDO THREAD PLACED IN THE MIDFACE AND LOWER FACE AREA ON (B)(6) 2022. ACCORDING TO THE HCP, ON (B)(6) 2022, ONE PDO THREAD MIGRATED AND EXTRUDED TOWARDS THE INSIDE OF THE PATIENT'S MOUTH NEAR THE ORAL COMMISSURE, TWO WEEKS POST-TREATMENT. HCP ALSO INFORMED THAT A WEEK LATER, OTHER PDO THREADS CAUSED A BUMP AT THE REAR OF THE PATIENT'S FACE UPON MOVEMENT. 07/09/2022, HCP CONFIRMED THE PDO THREAD WAS REMOVED, AND THE PATIENT WAS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 747053 | NOVATHREADS | PDO SUTURE | NEW | ECTODERMA DBA COSMOFRANCE | A289-22 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Female | Required Intervention |