POWER PROXI SONIC INTERDENTAL SYSTEM POWERED TAPERED BRUSH

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW1009080
MDR Report Key32871
Date Received1996-05-07
Date of Report1996-05-01
Date of Event1996-03-10
Date Added to Maude1996-05-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePOWER PROXI SONIC INTERDENTAL SYSTEM POWERED TAPERED BRUSH
Generic NamePOWERED,INTERDENTAL,TAPERED BRUSH
Product CodeKOJ
Date Received1996-05-07
ID NumberUS PATENT 5123841
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key34170
ManufacturerDENTIST PREFERRED INC.
Manufacturer Address301 OXFORD VALLEY RD STE 401 A YARDLEY PA 19067 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1996-05-07

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