MAUDE Adverse Event Report: SONOVA AG UNITRON DX MOXI JUMP R T 5; HEARING AID RECEIVER-IN-CANAL (RIC)

Model Number	0506269P6
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer initiated a follow up to further clarify circumstances of this incident and patient's outcome.6 days after the awareness date (on 5 dec), it was reported that the patient is doing well, but has not passed the hearing aids yet, is receiving restoralax and will receive another x-ray and medical consultation.A family member reported that the patient does not have a habit of putting anything in his mouth or swallowing anything not meant to and is suspecting that the patient was dreaming and might have confused his hearing aids with pills at night.The intended use of the device requires it to be small in size, so that it can be worn behind the ear and it contains build-in lithium ion battery, which is required for device to power up and function.This is a known and inherited risk of the device.Product's risk management file contains a risk item addressing this hazard.The manufacturer deemed that the benefit of the device outweighs the risk.The accompanied ifu contains a warning informing patients about that the device contains lithium button/coin battery, swallowing of the device is hazardous and is prompting patients to immediately consult a physician without any delay if such event occurred.Device is not available for the manufacturer's analysis as it's considered a biohazard.
Event or Problem Description
The patient accidentally swallowed one hearing aid while he was asleep.He woke up with a very sore throat and one of his hearing aids was missing.It was reported that the patient usually stores his hearing aids in a charger at night and that the patient might have confused them for his pills while dreaming.The patient went to the hospital and x-ray examination confirmed that the hearing aid is in patient's small intestine.At the time of this report, no further harm or injury was reported.
Additional Manufacturer Narrative
6 days after the awareness date (on nov 29th), it was reported that the patient is doing well, but has not passed the hearing aids yet, is receiving restoralax and will receive another x-ray and medical consultation.A family member reported that the patient does not have a habit of putting anything in his mouth or swallowing anything not meant to, and is suspecting that the patient was dreaming and might have confused his hearing aids with pills at night.10 days after awareness date, x-ray examintion confirmed that the the hearing aid is no longer in the patient's body.It is presumed that the hearing aid passed through patient's system naturally.The patient is doing great and no damage or injury has been caused due to this incident.The intended use of the device requires it to be small in size, so that it can be worn behind the ear and it contains build-in lithium ion battery, which is required for device to power up and function.This is a known and inherited risk of the device.Product's risk management file contains a risk item addressing this hazard.The manufacturer deemed that the benefit of the device outweighs the risk.The accompanied ifu contains a warning informing patients about that the device contains lithium button/coin battery, swallowing of the device is hazardous and is prompting patients to immediately consult a physician without any delay if such event occurred.Device is not available for the manufacturer (it would have been conidered a biohazard).This is the final report.

• Brand Name: UNITRON DX MOXI JUMP R T 5
• Common Device Name: HEARING AID RECEIVER-IN-CANAL (RIC)
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisrütistrasse 28; stafa, zurich 8712 ; SZ 8712
• MDR Report Key: 20876822
• Report Number: 3005085999-2024-00024
• Device Sequence Number: 8955561
• Product Code: OSM
• UDI-Device Identifier: 07613389340587
• UDI-Public: (01)07613389340587
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• 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,Followup
• Report Date (Section B): 11/29/2024

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: 0506269P6
• 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: 11/29/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2020
• 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: Other
• Patient Age: 89 YR
• Patient Sex: Male