MAUDE Adverse Event Report: UNKNOWN EAR IMPLANT; IMPLANT, COCHLEAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 11/27/2022

Event Type  Injury  

Event Description

I have implants in both ears which are causing me excruciating pain, they're causing extreme pressure and in my head and my ears, are bleeding.Progress.Com.Fda safety report id # (b)(4).

• Brand Name: EAR IMPLANT
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15894955
• MDR Text Key: 304740300
• Report Number: MW5113573
• Device Sequence Number: 1
• Product Code: MCM
• 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: 11/28/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White