MAUDE Adverse Event Report: INTEGRATED MICRO-ELECTRONICS INC. WIDEX; MOMENT MBB3D 220

Model Number	21002760
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	04/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a cross-reporting case from france.
Event or Problem Description
In this event, patient experienced a burn-like injury behind his ear, where the hearing aid is positioned.The device shows traces of white powder and the battery contacts are corroded.The patient's doctor called poison control center, to find out what action the patient should take.No further information on the treatment has been received.The battery compartment ensures that the battery does not get into direct contact with the skin.
Event or Problem Description
Results of technical investigation: hearing aid without battery was returned for investigation.Device is powered by zinc air battery; koh is the electrolyte in the battery.Trace of white powdery material observed in the battery compartment and door.Based on previous investigation findings, support that battery leakage of koh presents itself as a white powdery material which was found on the returned hearing aid.This has been seen previously in cases of corrosion, due to the presence of chlorine on the external surface of the battery.Chlorine is not a component used as an ingredient nor in the manufacturing process for hearing aid batteries.Chlorine exposure may have occurred after the battery was removed from the consumer packaging.
Additional Manufacturer Narrative
The condition of the battery plays a key role before use: it should be cleaned and stored as stated in the user guide.
Event or Problem Description
Patient update: patient has now fully recovered in this event; patient was cleaning the affected area and applying cream to aid in the healing process.Patient has pre-existing atopic skin condition, which caused the healing process to be delayed.Investigation conclusion: root cause cannot be confirmed because the battery was not returned.

• Brand Name: WIDEX
• Common Device Name: MOMENT MBB3D 220
• Manufacturer (Section D): INTEGRATED MICRO-ELECTRONICS INC.; north science avenue; laguna technopark; binan laguna, 4024 ; RP 4024
• Manufacturer Contact: lashaunda joseph ; 185 commerce dr.; hauppauge, NY 11788 ; 5617859321
• MDR Report Key: 19341050
• Report Number: 3013294311-2024-00035
• Device Sequence Number: 8687737
• Product Code: OSM
• UDI-Device Identifier: 05706069923254
• UDI-Public: 05706069923254
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• Report Date (Section B): 08/20/2024

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 Model Number: 21002760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/19/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: Male