MAUDE Adverse Event Report: SIVANTOS SP. Z O.O SIGNIA; INSIO 7PX CIC

Model Number	10936783
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event, patient ingested his hearing aid (without battery) and went to the emergency room.Patient was sent home and hearing aid was passed thru his body.Doctor confirmed the device was intact and customer is doing ok after the event.The shell is made of poly(methyl methacrylate) and polyamide.Swallowing the hearing aids is a misuse and is identified in the user guide.
Additional Manufacturer Narrative
Device was not made available for investigation because it is considered a biohazard after being ingested and passed by patient.We were made aware that our electronic submissions failed and were not received by fda.A capa was opened to address this issue and this report is being electronically resubmitted to correct the error of the first failed submissions (submitted on (b)(6) 2023).Distributor, importer and manufacturer are under the ws audiology compliance system.

• Brand Name: SIGNIA
• Common Device Name: INSIO 7PX CIC
• Manufacturer (Section D): SIVANTOS SP. Z O.O; przemyslowa 18; komorniki wielkopolskie, 62-05 2; PL 62-052
• Manufacturer Contact: la-shaunda joseph ; 101 wood avenue south; 7th floor; iselin, NJ 08830 ; 5617859321
• MDR Report Key: 18934515
• Report Number: 3014357822-2024-00031
• Device Sequence Number: 13084034
• Product Code: OSM
• UDI-Device Identifier: 04056839129753
• UDI-Public: 04056839129753
• Combination Product (Y/N): N
• Initial Reporter Country: IV
• 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
• Report Date (Section B): 03/19/2024

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: 10936783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2022
• 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: Other
• Patient Sex: Male