FDA Adverse Event
Other
Summary report: N
INVISALIGN SYSTEM
MDR report key: 1961703
·
Received January 11, 2011
Report
- Report Number
- 2953749-2008-00194
- Event Type
- Other
- Date Received
- January 11, 2011
- Date of Event
- August 28, 2008
- Report Date
- August 28, 2008
- Manufacturer
- ALIGN TECHNOLOGY
- Product Code
- NXC
- PMA / PMN Number
- K981095
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 OBSERVATIONS, (B)(4) ISSUED (B)(4) 2010.
Description of Event or Problem · 1
THE ATTENDING PHYSICIAN REPORTED THAT PATIENT NOTED THAT HIS WHOLE TONGUE SWELLED UP, AND THE PATIENT'S MOUTH WAS ALSO SWOLLEN, WHILE WEARING THE ALIGNERS. THE PATIENT WAS ON THE FIRST STAGE OF THE ALIGNERS, AND THE SWELLING STARTED ON THE 5TH DAY OF USE. THE PATIENT HAS A PRE-EXISTING HISTORY OF ANGIOEDEMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVISALIGN SYSTEM | SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE | NXC | ALIGN TECHNOLOGY | INVISALIGN FULL | 42576825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |