FDA Adverse Event
Injury
Summary report: N
NOVATHREADS
MDR report key: 17139998
·
Received June 15, 2023
Report
- Report Number
- 3007895168-2022-00062
- Event Type
- Injury
- Date Received
- June 15, 2023
- Report Date
- June 30, 2022
- Manufacturer
- ECTODERMA DBA COSMOFRANCE
- Product Code
- NEW
- PMA / PMN Number
- K160761
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ON 06/30/2022, HCP REPORTED THAT A PATIENT HAD MOLDED PDO THREAD IMPLANTED IN THE LOWER FACE JUST BELOW THE EAR, BUT THE PDO THREAD MIGRATED. ON 08/03/2022, AFTER CONSECUTIVE ATTEMPTS TO GATHER INFORMATION, HCP CONFIRMED THE PDO THREAD WAS REMOVED MENTIONING IT WAS SMOOTH UPON RETRIEVAL. HCP DIDN'T DISCLOSE ANY FURTHER DETAILS OR PATIENT STATUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2093536 | NOVATHREADS | PDO SUTURE | NEW | ECTODERMA DBA COSMOFRANCE | DW1C-MDA18100220113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |