DENT-X 810/9000 99992405001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-12-07 for DENT-X 810/9000 99992405001 manufactured by Dent-x.

Event Text Entries

[543118] We purchased a dent-x model 9992405001 810/900 daylight loader for our new dent-x model 810 x-ray processor. The daylight loader was installed according to the manufacturer's instructions. When we used the loader we found that it had a light leak in the area where it attaches to the processor. We contacted our supplier and they sent us another daylight loader. We inspected the unit and found it to have a light leak in the same area. We contacted the manufacturer and they denied that there was any problem with their product. Instead they blamed us for an incorrect installation. We made photographs which clearly demonstrated the light leak on the new, uninstalled unit and sent the photographs to the manufacturer. They continued to deny the existence of a problem with their product. We contacted one of the dental equipment suppliers who helps us when we have service needs. He told us that he always has problems with the dent-x equipment, that it is not a good design, and that he avoids selling it. We made suggestions to the manufacturer regarding how a simple modification would eliminate the problem, but they were not interested. We conveyed our concerns to the president of dent-x, but we never received a reply. We feel that this product places patients at risk for unnecessary exposure to x-ray radiation due to light leaks which result in the need for dental x-ray retakes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1041305
MDR Report Key792581
Date Received2006-12-07
Date of Report2006-12-07
Date of Event2006-09-01
Date Added to Maude2006-12-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDENT-X
Generic NameDAYLIGHT LOADER MODEL 9992405001 810/9000
Product CodeIXW
Date Received2006-12-07
Model Number810/9000
Catalog Number99992405001
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key780221
ManufacturerDENT-X
Manufacturer Address250 CLEARBROOK RD ELMSFORD NY 10523 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-12-07

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