MAUDE Adverse Event Report: UNKNOWN EAR PLUGS; PROTECTOR, HEARING (INSERT)

Device Problems Malposition of Device (2616); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2019

Event Type  Injury  

Event Description

During the mri scan the patient complained about loud noise from his right ear.We checked on him and found the larger ear plug was in his ear almost all the way.I was able to put it in further and used the small fold-ble cushion to keep it in place and somewhat cover his ear at the same time.We finished the exam without further complaint.

• Brand Name: EAR PLUGS
• Type of Device: PROTECTOR, HEARING (INSERT)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8315352
• MDR Text Key: 136233980
• Report Number: MW5083801
• Device Sequence Number: 2
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 70