WALLY'S *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-06 for WALLY'S * manufactured by Wally's.

Event Text Entries

[21694185] Patient used an ear candle. States she felt a burning sensation in her right ear. Our initial exam demonstrated what appeared to be "wax". On follow -up 1 week later, the tympanic membrane was examined and a perforation was identified.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1040425
• MDR Report Key: 760688
• Date Received: 2006-09-06
• Date of Report: 2006-09-06
• Date of Event: 2006-08-21
• Date Added to Maude: 2006-09-18
• 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: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WALLY'S
• Generic Name: EAR CANDLE
• Product Code: JYH
• Date Received: 2006-09-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 748606
• Manufacturer: WALLY'S
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-09-06