MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONNET; EXTERNAL COMPONENT

Model Number	SONNET BATTERY PACK COVER [OPUS 3 BP COVER]
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Gastritis (1874); Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Event or Problem Description
A two-year-old child swallowed a battery cell (# 675) and had to undergo fibroscopy under anesthesia and suffered after of a gastritis.
Event or Problem Description
A two year old child swallowed a battery cell (# 675) and had to undergo fibroscopy under anesthesia, and suffered after of a gastritis.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, a two year old child swallowed a zink air battery cell and had to undergo fibroscopy under anesthesia, and suffered after of a gastritis.Requested information has not been received, therefore it is currently unclear if the battery compartment lock was used.The user manual of the sonnet audio processor (aw31902) recommends that "when the user is a young child, the battery pack cover lock must always be turned clockwise into the locked position once the cover has been moved completely over the frame to prevent the child from disassembling the audio processor.Swallowing of system components could cause suffocation or internal injury." this is a final report.

• Brand Name: SONNET
• Common Device Name: EXTERNAL COMPONENT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 23048960
• Report Number: 9710014-2025-00837
• Device Sequence Number: 18577205
• Product Code: MCM
• UDI-Device Identifier: 09008737349257
• UDI-Public: (01)09008737349257
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SONNET BATTERY PACK COVER [OPUS 3 BP COVER]
• Device Lot Number: 34925
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 MO
• Patient Sex: Female