FDA Adverse Event
Other
Summary report: N
INVISALIGN SYSTEM
MDR report key: 1993324
·
Received February 7, 2011
Report
- Report Number
- 2953749-2010-00016
- Event Type
- Other
- Date Received
- February 7, 2011
- Date of Event
- February 17, 2010
- Report Date
- February 22, 2010
- Manufacturer
- ALIGN TECHNOLOGY, INC.
- Product Code
- NXC
- PMA / PMN Number
- K981095
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 483 INSPECTION OBSERVATION, FILE NUMBER (B)(4) ISSUED (B)(4) 2010.
Description of Event or Problem · 1
PT REPORTED SYMPTOMS OF A SORE THROAT, RASH, HIVES, AND RED BUMPS ON HER FACE, AFTER STARTING TREATMENTS USING THE ALIGNERS ON (B)(6) 2010. THE PT TOOK BENADRYL WHICH SEEMED TO HELP ALLEVIATE THE SYMPTOMS. THE PT DECIDED TO STOP TREATMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVISALIGN SYSTEM | SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE | NXC | ALIGN TECHNOLOGY, INC. | INVISALIGN FULL | 64774259 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other |