AUDIBEL A2 SILVER WIRELESS RIC 312

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-08 for AUDIBEL A2 SILVER WIRELESS RIC 312 manufactured by Audibel Hearing Aids.

Event Text Entries

[5934076] Hearing aid - ear canal portion broke off inside canal. Removal was performed, outpatient, by physician.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5043033
• MDR Report Key: 4838156
• Date Received: 2015-06-08
• Date of Report: 2015-05-31
• Date of Event: 2015-05-29
• Date Added to Maude: 2015-06-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: AUDIBEL A2 SILVER WIRELESS RIC 312
• Generic Name: AUDIBEL A2 SILVER WIRELESS RIC 312
• Product Code: OSM
• Date Received: 2015-06-08
• Operator: LAY USER/PATIENT
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AUDIBEL HEARING AIDS

Device Sequence Number: 2

• Brand Name: AUDIBEL A2 SILVER WIRELESS RIC 312
• Generic Name: AUDIBEL A2 SILVER WIRELESS RIC 312
• Product Code: OSM
• Date Received: 2015-06-08
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: AUDIBEL HEARING AIDS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2015-06-08