FDA Adverse Event
Other
Summary report: N
MICRO-ANGLE ATTACHMENT, 70 DEGREE
MDR report key: 463036
·
Received May 23, 2003
Report
- Report Number
- 1017294-2003-00031
- Event Type
- Other
- Date Received
- May 23, 2003
- Date of Event
- April 30, 2003
- Report Date
- April 30, 2003
- Manufacturer
- LINVATEC COR.
- Product Code
- GET
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A BURN OCCURRED ON LOWER LEFT LIP OF THE PT. THE AREA WAS APPROX 2-3CM IN DIAMETER AND TOOK OFF THE FIRST LAYER OF SKIN. ONLY INTERVENTION REQUIRED WAS VASELINE ON THE SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO-ANGLE ATTACHMENT, 70 DEGREE | DENTAL ATTACHMENT | GET | LINVATEC COR. | NA | AUG00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other |