DENTAPURE DP1 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-15 for DENTAPURE DP1 * manufactured by Mrlb International., Inc..

Event Text Entries

[539094] I am writing to report that a product named dentapure, which is a registered trademark of mrlb international, inc, is being marketed and sold inappropriately. Mrlb international misbrands, illegally advertises, and promotes their products by clearly implying to all reasonable consumers that their products have been approved and endorsed by the fda.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1040057
• MDR Report Key: 754976
• Date Received: 2006-08-15
• Date Added to Maude: 2006-08-29
• 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: 3
• Reporter Occupation: ATTORNEY
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: DENTAPURE DP1
• Generic Name: DENTAPURE CARTRIDGES
• Product Code: ELB
• Date Received: 2006-08-15
• Model Number: DP1
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 742788
• Manufacturer: MRLB INTERNATIONAL., INC.
• Manufacturer Address: 2450 COLLEGE WAY FRAGUS FALLS MN 56537 US

Device Sequence Number: 2

• Brand Name: DENTAPURE DP40
• Generic Name: DENTAPURE CARTRIDGES
• Product Code: ELB
• Date Received: 2006-08-15
• Model Number: DP40
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 743206
• Manufacturer: MRLB INTERNATIONAL, INC.
• Manufacturer Address: 2450 COLLEGE WAY FERGUS FALLS MN 56537 US

Device Sequence Number: 3

• Brand Name: DENTAPURE DP90
• Generic Name: DENTAPURE CARTRIDGES
• Product Code: ELB
• Date Received: 2006-08-15
• Model Number: DP90
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 743207
• Manufacturer: MRLB INTERNATIONAL, INC.
• Manufacturer Address: 2450 COLLEGE WAY FERGUS FALLS MN 56537 US

Device Sequence Number: 4

• Brand Name: DENTAPURE DP365
• Generic Name: DENTAPURE CARTRIDGES
• Product Code: ELB
• Date Received: 2006-08-15
• Model Number: DP365
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 743208
• Manufacturer: MRLB INTERNATIONAL, INC.
• Manufacturer Address: 2450 COLLEGE WAY FERGUS FALLS MN 56537 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-08-15