FDA Adverse Event
Other
Summary report: N
INVISALIGN SYSTEM
MDR report key: 1993357
·
Received February 7, 2011
Report
- Report Number
- 2953749-2008-00189
- Event Type
- Other
- Date Received
- February 7, 2011
- Date of Event
- August 12, 2008
- Report Date
- August 20, 2008
- Manufacturer
- ALIGN TECHNOLOGY, INC.
- Product Code
- NXC
- PMA / PMN Number
- K981095
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED OUTSIDE THE 30 DAY REQUIREMENT, AS THIS MDR FILING IS RELATED TO ALIGN TECHNOLOGY'S (B)(4) BASED ON FORM FDA (B)(4) INSPECTION OBSERVATION, (B)(4) ISSUED (B)(4) 2010.
Description of Event or Problem · 1
PT RECEIVED ALIGNERS ON (B)(6) 2008 AND SYMPTOMS APPEARED THAT EVENING. SYMPTOMS REPORTED: THROAT FELT LIKE IT WAS CLOSING UP, SOME DIFFICULTY IN BREATHING, A SORE THROAT, AND SINUSES FLARED UP. ON MONDAY (B)(6) 2008, THE PT DISCONTINUED THE ALIGNERS FOR TWO DAYS AND THE SYMPTOMS DISAPPEARED. THE PT AGAIN TRIED THE ALIGNERS AN THE SYMPTOMS RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVISALIGN SYSTEM | SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE | NXC | ALIGN TECHNOLOGY, INC. | INVISALIGN FULL | 43653343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |