WATERCHECK 2 * CM202-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-21 for WATERCHECK 2 * CM202-01 manufactured by Integrated Biomedical Technology, Inc..

MAUDE Entry Details

• Report Number: 2327105
• MDR Report Key: 2327105
• Date Received: 2011-10-21
• Date of Report: 2011-06-14
• Date of Event: 2011-05-20
• Report Date: 2011-06-14
• Date Reported to FDA: 2011-10-21
• Date Added to Maude: 2011-11-07
• Event Key: 0
• Report Source Code: User Facility 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: RISK MANAGER
• 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: WATERCHECK 2
• Generic Name: CHLORINE REAGENT STRIP
• Product Code: FKP
• Date Received: 2011-10-21
• Model Number: *
• Catalog Number: CM202-01
• Lot Number: JA233002
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRATED BIOMEDICAL TECHNOLOGY, INC.
• Manufacturer Address: 2931 MOOSE TRL ELKHART IN 46514 US 46514

Device Sequence Number: 2

• Brand Name: WATERCHECK 2
• Generic Name: CHLORINE REAGENT STRIP
• Product Code: FKP
• Date Received: 2011-10-21
• Model Number: *
• Catalog Number: CM202-01
• Lot Number: JC235002
• ID Number: *
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: INTEGRATED BIOMEDICAL TECHNOLOGY, INC.
• Manufacturer Address: 2931 MOOSE TRL ELKHART IN 46514 US 46514

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-10-21