MAUDE Adverse Event Report: WSAUD A/S SIGNIA; PURE C&G T 7AX

Model Number	10997100, 10993682
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We were made aware that our electronic submissions failed and were not received by fda.A capa was opened to address this issue and this report is being electronically resubmitted to correct the error of the first failed submissions (submitted on 08/23/2023).Distributor, importer and manufacturer are under the ws audiology compliance system.
Event or Problem Description
In this event, health care provider reported that patient had part of the receiver and tip of their hearing aid stuck in his ear canal.(unknown how long they were stuck in pt's ear) patient went to urgent care then to the emergency room to have removed, and they were unable to remove from patient's ear.Patient was then sent to mass eye and ear, where patient was given anti-anxiety medication and the tip/receiver was removed from his ear with use of numbing medication.Device was not returned by user for investigation.Investigators tested 30 samples of the ear tip dome and each sample met the pull test requirements (withstand 400g load longer than 10 seconds without falling off).Instructions for use are illustrated on the product packaging to ensure proper insertion of eartip 3.0 prior to use.Recommend user to follow the user guide instruction to change the eartip 3.0 regularly to avoid any incident.

• Brand Name: SIGNIA
• Common Device Name: PURE C&G T 7AX
• Manufacturer (Section D): WSAUD A/S; nymøllevej 6; lynge, 3540D NK; DA 3540DNK
• Manufacturer Contact: la-shaunda joseph ; 101 wood avenue south; 7th floor; iselin, NJ 08830 ; 5617859321
• MDR Report Key: 18933278
• Report Number: 0008021514-2024-00026
• Device Sequence Number: 14600339
• Product Code: OSM
• UDI-Device Identifier: 05714880119565
• UDI-Public: 5714880119565
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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 Model Number: 10997100, 10993682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male