MAUDE Adverse Event Report: STARKEY GLOBAL DISTRIBUTION CENTER HEARING AID EVOLVAL; HEARING AID, AIR CONDUCTION

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
My hearing aid turned off after passing through an anti-theft gate at a drug store.I could not turn the hearing aid back on for 20 minutes.Fda safety report id# (b)(4).

• Brand Name: HEARING AID EVOLVAL
• Common Device Name: HEARING AID, AIR CONDUCTION
• Manufacturer (Section D): STARKEY GLOBAL DISTRIBUTION CENTER
• MDR Report Key: 15503286
• Report Number: MW5112329
• Device Sequence Number: 15224588
• Product Code: ESD
• UDI-Device Identifier: 00842318185037
• UDI-Public: (01)00842318185037(11)220830(21)
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White