FDA Adverse Event
Injury
Summary report: N
EXCITEOSA
MDR report key: 17412315
·
Received July 28, 2023
Report
- Report Number
- 3017737771-2023-00033
- Event Type
- Injury
- Date Received
- July 28, 2023
- Date of Event
- June 30, 2023
- Report Date
- July 26, 2023
- Manufacturer
- SIGNIFIER MEDICAL TECHNOLOGIES
- Product Code
- QNO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
SEE REPORT ATTACHED.
Description of Event or Problem · 0
DARKENED MARKS ON TONGUE AND ASSOCIATED BURNING SHOCK-LIKE SENSATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2320653 | EXCITEOSA | EXCITEOSA | QNO | SIGNIFIER MEDICAL TECHNOLOGIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |