*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-03 for * manufactured by Nature's Way.

Event Text Entries

[65134] Rptr noted an add for ear candles at a health food store in west columbia. As noted from personal encounters and from medical literature these devices can deposit wax in ear canal. Reporter wants to urge the fda to ban these devices. They are a hoax. Please stop this device.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1011626
• MDR Report Key: 102991
• Date Received: 1997-07-03
• Date of Report: 1997-06-24
• Date Added to Maude: 1997-07-08
• 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
• 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: EAR CANDLES
• Product Code: JYH
• Date Received: 1997-07-03
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 101350
• Manufacturer: NATURE'S WAY
• Manufacturer Address: 1300 AUGUSTA RD. WEST COLUMBIA SC 29169 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-07-03
2	0		1997-07-03