MAUDE Adverse Event Report: CIRRUS HEALTCARE PRODUCTS, LLC / CIRRUS HEALTCARE PRODUCTS, LLC EARPLANES+; PROTECTOR, HEARING (INSERT)

Model Number FOR KIDS AND SMALLER EARS

Event Date 11/20/2023

Event Type  Injury  

Event Description

I recently purchased "earplanes+" by cirrus healthcare products, llc (https://www.Earplanes.Com) for an airplane flight and put them into my ear prior to take off and to my horror discovered they shot almost all the way into my ear canal and i could not remove them without help.They began to immediately cause pain in the ear due to how deep they were lodged inside the ear and because of their tiny shape and slippery silicone material just slid further into the ear the more i attempted to grab them and extract them from my ear.They have no safety design that stops them from sliding all of the way into the ear canal towards the ear drum and no way to remove them once they are past the outer ear.Luckily, my brother was with me and he had to ask the stewardess for a pair of tweezers to carefully grab a hold of the end of the earplanes and pull them out of my ear while the plane was already mid air.Had my brother not been with me on the flight, i would have been in pain the entire flight and they might have damaged my ear canal or ear drum from the constant pressure changes as the plane went up and down in altitude.These are a very dangerous product that should not be allowed for sale and should be immediately recalled before they hurt more innocent people or kids.I purchased the style labels for "kids and smaller ears" which are presumably smaller than the regular version but clearly indicate they can be used by adults and have no warnings whatsoever as to how dangerous they are if they slide too far into the ear.If i hadn't been careful they would have gone even further into my ear and would not have been removable on the plane by my brother and would have required a visit to a hospital emergency room with a doctor to remove them.

• Brand Name: EARPLANES+
• Type of Device: PROTECTOR, HEARING (INSERT)
• Manufacturer (Section D): CIRRUS HEALTCARE PRODUCTS, LLC / CIRRUS HEALTCARE PRODUCTS, LLC
• MDR Report Key: 18631048
• MDR Text Key: 334614353
• Report Number: MW5150999
• Device Sequence Number: 1
• Product Code: EWD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: FOR KIDS AND SMALLER EARS
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White