MAUDE Adverse Event Report: SIGNIA GMBH. SIGNIA; PURE CHARGE&GO 7X

Model Number	10963600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event, user went to urgent care to remove ear tip, but they could not get it out.The user guide cautions of potential risk of tip remaining in the ear with follow-up actions.There has been no further information provided by user, after several attempts to contact them concerning the event.Device has not been returned; therefore, no investigation can be completed.
Additional Manufacturer Narrative
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 08/04/2023).Distributor, importer and manufacturer are under the ws audiology compliance system.

• Brand Name: SIGNIA
• Common Device Name: PURE CHARGE&GO 7X
• Manufacturer (Section D): SIGNIA GMBH.; henri-dunant-strasse 100; erlangen, 91058 ; GM 91058
• Manufacturer Contact: la-shaunda joseph ; 101 wood avenue south; 7th floor; iselin, NJ 08830 ; 5617859321
• MDR Report Key: 18932662
• Report Number: 3005019184-2024-00021
• Device Sequence Number: 4540655
• Product Code: OSM
• UDI-Device Identifier: 04056839097427
• UDI-Public: 04056839097427
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 10963600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown