FDA Adverse Event
Malfunction
Summary report: N
2PRO PROPHY ANGLE
MDR report key: 13472560
·
Received February 7, 2022
Report
- Report Number
- 2511556-2022-00001
- Event Type
- Malfunction
- Date Received
- February 7, 2022
- Date of Event
- January 20, 2022
- Report Date
- February 7, 2022
- Manufacturer
- PREMIER DENTAL PRODUCTS COMPANY
- Product Code
- EHK
- UDI-DI
- D6915500102
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
AS PER DR. (B)(6), AN ASSISTANT AT THE OFFICE WAS USING THIS PROPHY ANGLE DURING A PROPHY PROCEDURE WHEN THE ITEM EXPLODED INSIDE OF A FEMALE PATIENT'S MOUTH WITH MINIMAL PRESSURE. THE TIP BROKE, PLASTIC RING BROKE IN HALF AND 3 METAL PIECES. THEY COULD ONLY FIND ALL PIECES THAT BROKE EXCEPT ONE METAL PIECE. THEY THEN SENT THE PATIENT FOR CHEST X-RAY (NO SIGN OF ANYTHING IN LUNGS) . THEY ARE NOT SURE IF SHE SWALLOWED THAT PIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 880367 | 2PRO PROPHY ANGLE | PROPHYLAXIS CUP | EHK | PREMIER DENTAL PRODUCTS COMPANY | 20210401 | D6915500102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Female | Required Intervention |