NAPAWATER DL THREE MODELS SOLD *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-30 for NAPAWATER DL THREE MODELS SOLD * manufactured by Proton Co.

Event Text Entries

[357482] Sold as houshold device to electrolyze water, thus freeing pure oxygen and hydrogen gas. This could introduce explosive hydrogen into unsuspecting people's kitchens.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1032279
• MDR Report Key: 531231
• Date Received: 2004-05-30
• Date of Report: 2004-05-30
• Date of Event: 2004-05-30
• Date Added to Maude: 2004-06-25
• 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
• Reporter Occupation: PATIENT
• 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: NAPAWATER DL
• Generic Name: HOME WATER ELECTROLYSIS
• Product Code: JJR
• Date Received: 2004-05-30
• Model Number: THREE MODELS SOLD
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 520484
• Manufacturer: PROTON CO
• Manufacturer Address: * * JA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-05-30