MAUDE Adverse Event Report: NTEGRATED MICRO-ELECTRONICS INC. SIGNIA; PURE 312 5AX

Catalog Number	10985812
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Discomfort (2330); Ear Pain (4812)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event, patient was removing hearing aid from ear when unkowning to the user, the dome had detached from the receiver and remained in ear canal.Patient continued to reinsert hearing aid for the following days, pushing the detached dome deeper into ear canal.Patient went to ent doctor who found the detached dome lodged in ear canal and was able to remove from ear.User reported pain and discomfort in the ear.Patient was prescribed an antibiotic.Results of technical investigation: hearing aids with eru wax guard were returned for investigation.Dome that was lodged in patient's ear was not returned.Devices that were returned were tested and are functioning within specification.User guide instructs patient to seek assistance from medical professional should a piece remain in the ear.
Additional Manufacturer Narrative
Cross reporting case from canada.

• Brand Name: SIGNIA
• Common Device Name: PURE 312 5AX
• Manufacturer (Section D): NTEGRATED MICRO-ELECTRONICS INC.; north science avenue; binan laguna, PH 4 024; RP PH 4024
• Manufacturer Contact: la-shaunda joseph ; 101 wood avenue south; 7th floor; iselin, NJ 08830 ; 5617859321
• MDR Report Key: 19632401
• Report Number: 3013294311-2024-00038
• Device Sequence Number: 7065453
• Product Code: OSM
• UDI-Device Identifier: 05714880154627
• UDI-Public: 05714880154627
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 10985812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown