STARKEY MUSE RIC MUSERIC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-17 for STARKEY MUSE RIC MUSERIC manufactured by Starkey Laboratories Inc..

MAUDE Entry Details

• Report Number: MW5088203
• MDR Report Key: 8802910
• Date Received: 2019-07-17
• Date of Report: 2019-07-17
• Date of Event: 2018-08-07
• Date Added to Maude: 2019-07-18
• 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: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: STARKEY MUSE RIC
• Generic Name: HEARING AID, AIR CONDUCTION
• Product Code: ESD
• Date Received: 2019-07-17
• Model Number: MUSERIC
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STARKEY LABORATORIES INC.

Device Sequence Number: 2

• Brand Name: STARKEY MUSE RIC
• Generic Name: HEARING AID, AIR CONDUCTION
• Product Code: ESD
• Date Received: 2019-07-17
• Model Number: MUSERIC
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: STARKEY LABORATORIES INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-07-17