MAUDE Adverse Event Report: WSAUD A/S WIDEX; MOMENT MRR2D 440

Model Number	8 413 0140 120
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No investigation possible, as the device was discarded after surgery.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 07/17/2023).Distributor, importer and manufacturer are under the ws audiology compliance system.
Event or Problem Description
In this event, patient ingested her right hearing aid, went to her hcp and was provided with medication to aid in the "passing" of device; patient was unable to pass it on her own and required surgery to remove.Patient had successful surgery to remove the ingested battery.Patient had accidentally swallowed the hearing aid thinking they were pills prior to falling asleep.There is a warning statement included in the device user guide in case of battery being swallowed.

• Brand Name: WIDEX
• Common Device Name: MOMENT MRR2D 440
• Manufacturer (Section D): WSAUD A/S; nymoellevej 6; lynge DK-35 40; DA DK-3540
• Manufacturer Contact: la-shaunda joseph ; 185 commerce dr.; hauppauge, NY 11788 ; 5617859321
• MDR Report Key: 18929690
• Report Number: 0008021514-2024-00019
• Device Sequence Number: 9364695
• Product Code: OSM
• UDI-Device Identifier: 05706069884609
• UDI-Public: 05706069884609
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• 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: 8 413 0140 120
• Device Catalogue Number: 10985489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female