MAUDE Adverse Event Report: INTEGRATED MICRO-ELECTRONICS INC. WIDEX; MOMENT MBR3D 440

Catalog Number	21007218, 21006781
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event, user claims that their hearing aid combusted while charging in the charger.User states that the device caught on fire and he was able to extinguish it.The device was placed on the microwave in a bookshelf in the kitchen/living room.No report of damage besides charger and hearing aid.User said he burned his fingers but no medical intervention reported.
Event or Problem Description
Results of technical investigation: the battery was not returned, so its role in the incident cannot be confirmed.Evidence suggests the thermal event originated near the bottom of the device, specifically in the power supply module (psm) area.It is important to note that the psm was not returned for further evaluation.The risk of a battery cell shorting leading to the melting of the hearing aid housing appears to be low.A conclusive determination regarding a potential device malfunction cannot be made without the return of all relevant items and components.There are possibly two explanations in this case; the overheating was caused by either an external heat source or from a thermal runaway event resulting in the rapid release of heat that charred and deformed nearby plastic components.The presence of burn marks on the charger supports external heating.We were informed by the user that the device was placed on a microwave.The charger is still functional after this event.Additionally, no further information regarding the burned finger has been received from the user, and there have been no reports of medical intervention.

• Brand Name: WIDEX
• Common Device Name: MOMENT MBR3D 440
• Manufacturer (Section D): INTEGRATED MICRO-ELECTRONICS INC.; north science avenue; laguna technopark-special econ; binan laguna, 4024 ; RP 4024
• Manufacturer Contact: la-shaunda joseph ; 185 commerce dr; hauppauge, NY 11788 ; 5617859321
• MDR Report Key: 22976314
• Report Number: 3013294311-2025-00007
• Device Sequence Number: 18385722
• Product Code: OSM
• UDI-Device Identifier: 05706069870510
• UDI-Public: 05706069870510
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 11/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 21007218, 21006781
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Male