MAGNETIC DENTAL CHAIR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-23 for MAGNETIC DENTAL CHAIR manufactured by Adec Inc.

Event Text Entries

[1056918] I am a registered dental hygienist and educator. I travel around the country doing educational programs for dentists and dental hygienists. In doing my due diligence, i recently came across info that had never been discussed in dentistry, that could be a potential problem for patients with pacemakers and defibrillators. Boston scientific sent me a sheet that they make available to dentists and physicians titled "dental equipment and implantable pacemakers and defibrillators" and gives contraindications. They just added a new one that has me concerned. They discuss dental chairs with magnetic headrests. I contacted the top 5 manufacturer of dental chairs, and none of them had any idea what the strength of their magnets were. Midmark actually did some research and got back to say that they had headrest. According to your cardio department, it only takes 6-10 gauss to control the device. My reason for looking into this and reporting this is after talking with rptr, thought that this might be the best way to see if there are any incidents reported that would have lead boston scientific to add this to their contraindications. And if there is a concern, i would like to start educating dentist any hygienists on the potential risk. I appreciate your looking into this matter.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW5010470
MDR Report Key1351615
Date Received2009-03-23
Date of Report2009-03-23
Date Added to Maude2009-05-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameMAGNETIC DENTAL CHAIR
Generic NameMAGNETIC DENTAL CHAIR
Product CodeKLC
Date Received2009-03-23
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerADEC INC

Device Sequence Number: 2

Brand NameMAGNETIC DENTAL CHAIR
Generic NameMAGNETIC DENTAL CHAIR
Product CodeINN
Date Received2009-03-23
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No2
Device Event Key0
ManufacturerPELTON CRANE

Device Sequence Number: 3

Brand NameMAGNETIC DENTAL CHAIR
Generic NameMAGNETIC DENTAL CHAIR
Product CodeKLC
Date Received2009-03-23
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No3
Device Event Key0
ManufacturerMIDMARK

Device Sequence Number: 4

Brand NameMAGNETIC DENTAL CHAIR
Generic NameMAGNETIC DENTAL CHAIR
Product CodeKLC
Date Received2009-03-23
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No4
Device Event Key0
ManufacturerDENTAL-EZ

Device Sequence Number: 5

Brand NameMAGNETIC DENTAL CHAIR
Generic NameMAGNETIC DENTAL CHAIR
Product CodeKLC
Date Received2009-03-23
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No5
Device Event Key0
ManufacturerBELMONT

Device Sequence Number: 6

Brand NameBOSTON SCIENTIFIC
Generic NamePACEMAKERS
Product CodeDXY
Date Received2009-03-23
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No6
Device Event Key0
ManufacturerCONTRAINDICATION FOR DENTAL TREATMENT

Device Sequence Number: 7

Brand NameBOSTON SCIENTIFIC
Generic NameDEFIBRILLATORS
Product CodeLWS
Date Received2009-03-23
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No7
Device Event Key0
ManufacturerCONTRAINDICATION FOR DENTAL TREATMENT

Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-03-23
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