MAUDE Adverse Event Report: SOUND QUEST, LLC ENRICH PRO ITC; HEARING AID, AIR-CONDUCTION, OVER THE COUNTER

Model Number 10078

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This report or other information submitted by hearing lab technology llc under 21 cfr part 803, and release by fda of that report information, does not reflect a conclusion or admission by hearing lab technology llc, its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.

Event Description

It was reported to the importer, by the end user, patient was pulling the hearing aid out of the ear canal by the pull string and it came apart.Patient said they had to get a friend to get the part of the hearing aid out of the ear.

• Brand Name: ENRICH PRO ITC
• Type of Device: HEARING AID, AIR-CONDUCTION, OVER THE COUNTER
• Manufacturer (Section D): SOUND QUEST, LLC; 806 beaver st; west bristol PA 19007
• MDR Report Key: 18005839
• MDR Text Key: 326524445
• Report Number: 2523532-2023-00003
• Device Sequence Number: 1
• Product Code: QUF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10078
• Device Catalogue Number: 10078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2023
• Distributor Facility Aware Date: 09/25/2023
• Device Age: 5 MO
• Event Location: Other
• Date Report to Manufacturer: 10/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male