EAR CANDLING

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-14 for EAR CANDLING manufactured by White Sands Salon And Day Spa.

Event Text Entries

[2393462] A "friend" who works at the (b)(6) salon and day spa in (b)(6) suggested an ear candling service. On (b)(6) 2012, (b)(6) performed ear candling. On (b)(6) 2012, i had severe ear pain and it was reported to a salon employee which went ignored. On (b)(6) 2012, my pain level increased to a 10 out of 10, i had hearing impairment as well as a fluid leakage. The urgent care doctor diagnosed me with ruptured ear drum capillaries, "bruising" of the ear drum, with a possible secondary infection of mastoiditis as a result of trauma to the inner ear. On (b)(6) 2012, i contacted the salon owner, (b)(6), to inform her of the result of my treatment at her salon. (b)(6) has yet to return my call. On (b)(6) 2012, my symptoms have not resolved and in some aspects worsened, so i sought further care from the (b)(6) ear associates. More in depth analysis of my ear structures and function were performed. The result was a diagnosis of: rupturing of ear drum capillaries and a first degree burn. My ear pain is a consistent 8 out of 10 and my hearing difficulties continue. It feels like my ear is "underwater. " i still have yet to hear back from the salon in terms of acknowledging my condition as a result of the treatment received. (b)(6) salon and day spa, (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5024269
• MDR Report Key: 2462538
• Date Received: 2012-02-14
• Date of Report: 2012-02-14
• Date of Event: 2012-02-01
• Date Added to Maude: 2012-02-22
• 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: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EAR CANDLING
• Generic Name: EAR CANDLE
• Product Code: JYH
• Date Received: 2012-02-14
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WHITE SANDS SALON AND DAY SPA
• Manufacturer Address: 4959 KATELLA AVE #C AND D LOS ALAMITOS CA 90720 US 90720

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2012-02-14