FDA Adverse Event
Injury
Summary report: N
BRACKET, METAL, ORTHODONTIC
MDR report key: 7043229
·
Received November 17, 2017
Report
- Report Number
- 2016150-2017-00006
- Event Type
- Injury
- Date Received
- November 17, 2017
- Date of Event
- January 31, 2014
- Report Date
- November 14, 2017
- Manufacturer
- ORMCO CORPORATION
- Product Code
- EJF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ORMCO CORPORATION WAS NOTIFIED BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES THAT A COMPLAINT HAD BEEN REGISTERED WITH REGARD TO THE ALLEGED SERIOUS INJURY. SPECIFIC PATIENT INFORMATION WAS NOT PROVIDED; THEREFORE WE ARE UNABLE TO RECEIVE FURTHER INFORMATION. THE PRODUCT INVOLVED IN THIS INCIDENT WAS NOT RETURNED THEREFORE NO EVALUATION CAN BE CONDUCTED.
Description of Event or Problem · 1
IT WAS ALLEGED THAT THE ORTHODONTIC BRACKETS MADE THE PATIENT MENTALLY UNSTABLE AND EXPERIENCED DAMAGE TO THEIR TEETH AND GUMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 819342 | BRACKET, METAL, ORTHODONTIC | EJF | ORMCO CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| S |