FDA Adverse Event
Injury
Summary report: N
LATERA 20MM, FINAL KIT
MDR report key: 16532914
·
Received March 13, 2023
Report
- Report Number
- 3006345872-2023-00001
- Event Type
- Injury
- Date Received
- March 13, 2023
- Date of Event
- February 13, 2023
- Report Date
- March 13, 2023
- Manufacturer
- ENTELLUS MEDICAL, INC.
- Product Code
- NHB
- PMA / PMN Number
- K161191
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE NOT AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT AT THE POST OP PROCEDURE VISIT THE LATERA IMPLANT HAD EXTRUDED FROM THE SURGICAL SITE. THE DOCTOR PERFORMED AN ADDITIONAL PROCEDURE TO REMOVE THE IMPLANT. NO ADDITIONAL ADVERSE CONSEQUENCES, WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 976579 | LATERA 20MM, FINAL KIT | LATERA ABSORBABLE NASAL | NHB | ENTELLUS MEDICAL, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |