*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-02 for * manufactured by Frontier Colon Cleansing.

Event Text Entries

[380239] The dept of state health services is alerting this office that the manufacturer of a colon hydrotherapy rectal tube is not registered with the fda as a device manufacturer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003900
• MDR Report Key: 594337
• Date Received: 2005-02-02
• Date of Report: 2004-12-20
• Date Added to Maude: 2005-04-25
• 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
• 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: *
• Generic Name: RECTAL TUBE
• Product Code: GBT
• Date Received: 2005-02-02
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 584163
• Manufacturer: FRONTIER COLON CLEANSING
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-02-02