FDA Adverse Event
Injury
Summary report: N
POWER PROXI SONIC INTERDENTAL SYSTEM POWERED TAPERED BRUSH
MDR report key: 32871
·
Received May 7, 1996
Report
- Report Number
- MW1009080
- Event Type
- Injury
- Date Received
- May 7, 1996
- Date of Event
- March 10, 1996
- Report Date
- May 1, 1996
- Manufacturer
- DENTIST PREFERRED INC.
- Product Code
- KOJ
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
PT IS VERY CONCERNED ABOUT HER LOSS. THIS BRUSH SYSTEM HAS A THICK WIRE AND LOOP AT TIP END TO HOLD THE BRISTLES. THE THICK LOOP AT THE TIP IN THIS PT WITH TIGHT INTERDENTAL SPACE HAS CAUSED HER DISCOMFORT. THE PRESSURE ON TISSUE & ESPECIALLY BONE WILL CAUSE IRREPARABLE BONE LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWER PROXI SONIC INTERDENTAL SYSTEM POWERED TAPERED BRUSH | POWERED,INTERDENTAL,TAPERED BRUSH | KOJ | DENTIST PREFERRED INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |