MAUDE Adverse Event Report: SIVANTOS PTE LTD TRUHEARING; TH ADVANCED 6 RIC LI

Catalog Number	21010684
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ear infection (4813)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event, the patient had experienced multiple infections.He was originally fitted for hearing aids on (b)(6) 2023.Patient was seen twice by ent in (b)(6) for otagilia and otidus externa.Patient was prescribed ear drops, antibiotics and prednisone for treatment.Per the healthcare provider, patient has not been seen since the occurence and will no longer be wearing hearing aids.Results of technical investigation found the returned devices have been investigated without any objections.It is unlikely that new hearing aid products can contaminate the patients skin with bacterium or virus which can cause an otits.Closing the ear canal with ear molds or domes, might support an existing otitis infection.Used domes or sleeves may close the ear canal and support a humid climate which may promote an otitis.All materials which are in contact with customers skin were tested for their biocompatibility based on iso-10993-1.No further investigation can be done.
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 11/17/2023).Distributor, importer and manufacturer are under the ws audiology compliance system.

• Brand Name: TRUHEARING
• Common Device Name: TH ADVANCED 6 RIC LI
• Manufacturer (Section D): SIVANTOS PTE LTD; 18 tai seng street; #08-08; singapore south east 53977 5; SN 539775
• Manufacturer Contact: la-shaunda joseph ; 101 wood avenue south; 7th floor; iselin, NJ 08830 ; 5617859321
• MDR Report Key: 18941188
• Report Number: 3003426343-2024-00029
• Device Sequence Number: 14176725
• Product Code: OSM
• UDI-Device Identifier: 05714880146875
• UDI-Public: 05714880146875
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/20/2024

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: 21010684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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: Male