FDA Adverse Event
Malfunction
Summary report: Y
LATERA 24MM, FINAL KIT
MDR report key: 19823125
·
Received July 24, 2024
Report
- Report Number
- 3006345872-2024-00012
- Event Type
- Malfunction
- Date Received
- July 24, 2024
- Date of Event
- June 30, 2024
- Report Date
- July 24, 2024
- Manufacturer
- ENTELLUS MEDICAL, INC.
- Product Code
- NHB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS 1 DEVICE WAS RECEIVED. ADDITIONAL INFORMATION 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.
Description of Event or Problem · 0
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE USED WAS REPORTEDLY EXPIRED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2302687 | LATERA 24MM, FINAL KIT | POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE | NHB | ENTELLUS MEDICAL, INC. | VMSR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |