FDA Adverse Event
Injury
Summary report: N
PALATAL ARCH
MDR report key: 18363745
·
Received December 20, 2023
Report
- Report Number
- 2126683-2023-00001
- Event Type
- Injury
- Date Received
- December 20, 2023
- Date of Event
- May 30, 2023
- Report Date
- December 19, 2023
- Manufacturer
- AMERICAN ORTHODONTICS
- Product Code
- DYJ
- UDI-DI
- 00190746133411
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DEVICE RETURNED TO AMERICAN ORTHODONTICS FOR EVALUATION. PRODUCT APPEARED TO BE INTACT; IT WAS NOT BROKEN OR FRACTURED. APPEARED THAT THE PRODUCT DEFORMED/BENT BY THE USER. CANNOT CONFIRM THE PRODUCT WAS MADE BY AMERICAN ORTHODONTICS BUT CANNOT RULE OUT THIS POSSIBILITY. NO ADDITIONAL DETAIL WAS PROVIDED BY THE RESPONDENTS REGARDING THE INCIDENT, DESPITE MULTIPLE ATTEMPTS BY AMERICAN ORTHODONTICS. IT REMAINS UNCLEAR HOW THE PRODUCT WAS USED.
Description of Event or Problem · 0
PRODUCT WAS SWALLOWED BY THE PATIENT AND HAD TO BE SURGICALLY REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1957776 | PALATAL ARCH | PALATAL ARCH | DYJ | AMERICAN ORTHODONTICS | 852-543L | Q14767 | 00190746133411 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |