FDA Adverse Event
Malfunction
Summary report: N
DAMON UTILITY OPENING/CLOSING PLIER
MDR report key: 686384
·
Received March 10, 2006
Report
- Report Number
- 2016150-2006-00022
- Event Type
- Malfunction
- Date Received
- March 10, 2006
- Date of Event
- February 1, 2006
- Report Date
- February 24, 2006
- Manufacturer
- ORMCO CORP.
- Product Code
- JEX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IN 2006 A DR INFORMED ORMCO CORP THAT HE HAD DAMON UTILITY OPENING/CLOSING PLIERS WITH BROKEN TIP INSERTS, BRAZE FAILURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DAMON UTILITY OPENING/CLOSING PLIER | PLIER, ORTHODONTIC | JEX | ORMCO CORP. | NA | 04L26L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |