MAUDE Adverse Event Report: WSAUD A/S. SIGNIA; INSIO C&G 7AX ITE

Catalog Number	21011146
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
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 07/11/2023) distributor, importer and manufacturer are under the ws audiology compliance system.
Event or Problem Description
In this event, patient was working outside on his truck, turned and heard a loud crack and pop.Patient states that something didn't feel right, he reached up to tap the hearing aid to readjust and there was blood pouring along the side of his face.His hearing aid had shattered into pieces while still connected to his ear.There was medical intervention and injury as stated in the complaint file.Patient went to clinic where the hcp observed 2 lacerations in the concha near the aperture of the canal and otoscopy revealed evidence of blood to the second bend.Hcp advised patient to go to the emergency room, but patient did not.Patient informed hcp the next day that there are no lacerations or burning in the ear canal, although there is dried blood in the canal that the patient has been removing at home.Investigation results: results from techinical investigation found the returned device had been manipulated; there was a visible marking of penetration with sharp/hard object on the faceplate and lacquered shell had been grinded down.This manipulation may have compromised the integrity of the shell and lead directly to the described failure (device broke into pieces) which weakened the shell significantly.The following warnings are provided in the user guide (d00168097) : do not use obviously damaged devices.Note that any unauthorized changes to the product may cause damage to the product or cause injury.

• Brand Name: SIGNIA
• Common Device Name: INSIO C&G 7AX ITE
• Manufacturer (Section D): WSAUD A/S.; nymoellevej 6; lynge, DK-35 40; DA DK-3540
• Manufacturer Contact: la-shaunda joseph ; 101 wood avenue south; 7th floor; iselin, NJ 08830 ; 5617859321
• MDR Report Key: 18888251
• Report Number: 0008021514-2024-00018
• Device Sequence Number: 16916330
• Product Code: OSM
• UDI-Device Identifier: 05714880148688
• UDI-Public: 05714880148688
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 21011146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2022
• 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: Required Intervention
• Patient Sex: Male