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 Number: MW1026397
• MDR Report Key: 421033
• Date Received: 2002-10-10
• Date of Report: 2002-10-10
• Date Added to Maude: 2002-10-10
• 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

Device Details

• Brand Name: SULTAN
• Generic Name: DOUBLE FLUORIDE TRAY
• Product Code: KMT
• Date Received: 2002-10-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 410068
• Manufacturer: SULTAN
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-10-10