FDA Adverse Event
Malfunction
Summary report: N
REGENCY WEINGART PLIER
MDR report key: 565776
·
Received January 7, 2005
Report
- Report Number
- 1643189-2005-00001
- Event Type
- Malfunction
- Date Received
- January 7, 2005
- Date of Event
- December 8, 2004
- Report Date
- December 9, 2004
- Manufacturer
- ORTHO-MED INTERNATIONAL, INC.
- Product Code
- JEX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ORTHODONITIC RESIDENT WHILE UNDER SUPERVISION OF AN ORTHODONTIST WAS ADJUSTING AN ORTHODONTIC WIRE ON A PT. THE INSTRUMENT THEY WERE USING BROKE AND A SMALL RIP OF THE INSTRUMENT WAS SWALLOWED BY THE PT. VERY MINOR ABRASIONS WERE APPARENT IN THE PT'S MOUTH. AS SCHOOL POLICY THE PT WAS TAKEN TO THE X-RAY LAB AND THE TIP CLEARLY WAS REVEALED IN THE DIGESTIVE SYSTEM. FOLLOW UP X-RAYS WERE TAKEN 5 DAYS LATER, AND THE TIP HAD PASSED. NO INTERVENTION WAS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REGENCY WEINGART PLIER | ORTHODONTIC PLIER | JEX | ORTHO-MED INTERNATIONAL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Other | ORTHODONTIC WIRE |