MAUDE Adverse Event Report: WAXTRACTOR EAR WAX REMOVAL KIT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 09/17/2018

Event Type  No Answer Provided  

Event Description

I purchased a waxtractor ear wax removal kit from (b)(6) on (b)(6) 2018.After using this product, the tip attached to the hose connected to the water bottle shot into my ear after squeezing the bottle trigger.The tip lodged into my ear canal causing a severe and painful ear infection, that now has resulted into a ringing in my right ear.I have contacted both (b)(6) and kruworks llc the vendor but to no avail.Document number: (b)(4).Report number: (b)(4).Kruworks llc.Email kruworks on (b)(6) 2018.

• Brand Name: WAXTRACTOR EAR WAX REMOVAL KIT
• Type of Device: WAXTRACTOR EAR WAX REMOVAL KIT
• MDR Report Key: 8186564
• MDR Text Key: 131476872
• Report Number: MW5082377
• Device Sequence Number: 1
• Product Code: OGQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR