FDA Adverse Event
Malfunction
Summary report: N
WONDERFUL DENTAL-DISTRIBUTOR
MDR report key: 21829260
·
Received April 11, 2025
Report
- Report Number
- 1051594-2025-00001
- Event Type
- Malfunction
- Date Received
- April 11, 2025
- Report Date
- March 10, 2025
- Manufacturer
- TEAM TECHNOLOGIES, INC
- Product Code
- EGS
- PMA / PMN Number
- K941189
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
HI, I WANTED TO REACH OUT REGARDING AN ORDER OF PROPHY ANGLES THAT OUR OFFICE RECENTLY PURCHASED. UNFORTUNATELY, WE ARE UNABLE TO USE THIS PRODUCT BECAUSE IT MAY POSE AS A CHOKING HAZARD. THE RUBBER TIP CAME OFF AND FELL TO THE BACK OF THE MOUTH WHILE USING ON A 2-YEAR-OLD. THE HYGIENIST WAS ABLE TO SWIFTLY RETRIEVE THE TIP WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2350550 | WONDERFUL DENTAL-DISTRIBUTOR | DISPOSABLE PROPHY ANGLE | EGS | TEAM TECHNOLOGIES, INC | 752402/10010 | 41014014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 MO | Unknown | Required Intervention |