MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-07 for POWER PROXI SONIC INTERDENTAL SYSTEM POWERED TAPERED BRUSH manufactured by Dentist Preferred Inc..
[18616]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009080 |
| MDR Report Key | 32871 |
| Date Received | 1996-05-07 |
| Date of Report | 1996-05-01 |
| Date of Event | 1996-03-10 |
| Date Added to Maude | 1996-05-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWER PROXI SONIC INTERDENTAL SYSTEM POWERED TAPERED BRUSH |
| Generic Name | POWERED,INTERDENTAL,TAPERED BRUSH |
| Product Code | KOJ |
| Date Received | 1996-05-07 |
| ID Number | US PATENT 5123841 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34170 |
| Manufacturer | DENTIST PREFERRED INC. |
| Manufacturer Address | 301 OXFORD VALLEY RD STE 401 A YARDLEY PA 19067 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-05-07 |