MAUDE Adverse Event Report: INTEGRATED MICRO-ELECTRONICS INC. (IMI) MIRACLE EAR; MEENERGY R 4 XP

Catalog Number	10973900S
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned for investigation, as the ingested device is considered a biohazard.
Event or Problem Description
In this event, the patient swallowed their hearing aid.Patient went to the hospital, where the provider stated that it was too late to perform an endoscopy and to wait for the aid to pass naturally.Provider confirmed that the patient has passed the hearing aid naturally, and has not experienced any adverse reactions.

• Brand Name: MIRACLE EAR
• Common Device Name: MEENERGY R 4 XP
• Manufacturer (Section D): INTEGRATED MICRO-ELECTRONICS INC. (IMI); north science avenue; laguna technopark-special econ; binan laguna, 4024 ; RP 4024
• Manufacturer Contact: la-shaunda joseph ; 101 wood avenue south; 7th floor; iselin, NJ 08830 ; 5617859321
• MDR Report Key: 20509783
• Report Number: 3013294311-2024-00041
• Device Sequence Number: 9088021
• Product Code: OSM
• UDI-Device Identifier: 04056839115275
• UDI-Public: 04056839115275
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/22/2024

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: 10973900S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2024
• 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: Female