SULTAN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-10 for SULTAN * manufactured by Sultan.

Event Text Entries

[20433990] When these trays are used for young children they tend to choke, gag, and vomit. There have been 2 pts (pediatric) who died after they used the device. Rptr will not use these devices on pts. Rptr feels that they should be outlawed for children. They choke, gag, and vomit when using these devices.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1026397
MDR Report Key421033
Date Received2002-10-10
Date of Report2002-10-10
Date Added to Maude2002-10-10
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 NameSULTAN
Generic NameDOUBLE FLUORIDE TRAY
Product CodeKMT
Date Received2002-10-10
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key410068
ManufacturerSULTAN
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2002-10-10

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