MAUDE Adverse Event Report: 3M COMPANY 3M EAR PLUGS; PROTECTOR, HEARING (INSERT)

Patient Problems Ambulation Difficulties (2544); Balance Problems (4401); Partial Hearing Loss (4472)

Event Date 11/08/2023

Event Type  Injury  

Event Description

Patient called to report a product issue and adverse event involving 3m ear plugs she was instructed to use in the us army.Patient stated after she enlisted in the us army, she was instructed to use the ear plugs while on the rifle range and says she used them over a 90-day period.She stated that she experienced hearing loss during that time and was advised she needs a hearing aid.Patient also stated she experiences balance problems before walking and while walking and says her gait is off.Patient stated she feels that she is at risk of falling.

• Brand Name: 3M EAR PLUGS
• Type of Device: PROTECTOR, HEARING (INSERT)
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 18758016
• MDR Text Key: 335998483
• Report Number: MW5151794
• Device Sequence Number: 1
• Product Code: EWD
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Female