MAUDE Adverse Event Report: SIVANTOS PTE LTD MIRACLE EAR; MEMINI RF 2XP

Model Number	10998457
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ear infection (4813)
Date of Event	07/18/2023
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 submission.(submitted on 08/17/2023) distributor, importer and manufacturer are under the ws audiology compliance system.
Event or Problem Description
In this event, the end user went to his health care provider ((b)(6) 2023) and it was discovered that the dome of the ha was stuck in his ear and had caused an infection.Patient was unaware at the time that dome had been stuck in ear.User was advised by the health care provider to go to urgent care.Patient went to health care provider for follow up appointment ((b)(6) 2023) and his infection has cleared up; patient is feeling better.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: MIRACLE EAR
• Common Device Name: MEMINI RF 2XP
• 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: 18932872
• Report Number: 3003426343-2024-00023
• Device Sequence Number: 18482976
• Product Code: OSM
• UDI-Device Identifier: 04056839098707
• UDI-Public: 4056839098707
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 10998457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2022
• 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