MUSE I1600 WIRELESS MUSE I 1600 WIRELESS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for MUSE I1600 WIRELESS MUSE I 1600 WIRELESS manufactured by Starkey Lab Hearing Aid Co..

Event Text Entries

[109044955] On (b)(6) 2016 (b)(6) was examined and signed a hearing aids sales contract with dr. (b)(6) pc. They gave the patient a 15 day trial period. Yet, 30 days thereafter, the 2 devices stopped working. They were sent back for repair from the dispensary at (b)(6) medical center, (b)(6). The devices were returned and signed for in 7 days. The last week of (b)(6), the devices started making loud noises and we noticed that the ears were emitting a liquid substance. My name is (b)(6), (b)(6) son. I advised my mom to stop wearing the devices until we cleared up her ears and got the devices checked. In january, 2017 i returned the devices to the dispensary and they were sent out again for repair. (b)(6) stopped wearing these devices for most of the year 2017 because we needed to see an ear, nose, and throat specialist to find out about the discharge coming from her ears. On (b)(6) 2017 we saw dr. (b)(6) at (b)(6) medical center. The doctor prescribed ear drops which cleared away the discharge from her ears. On (b)(6) 2018, the hearing aids had stopped working and was returned to downstate dispensary for repair. When the devices were returned they started making loud noises and caused another discharge from the ear. We stopped use again while we searched for an agency that would offer auditory services the devices were dropped off for repair again on 05/03/2018. We have experienced problems with these devices from the outset and went to another doctor to help with her hearing problem and different devices. Our complaint which is based on the use and non use of these devices, plus industry standards for comparable devices, that these hearing aids were not certified as new items. Based on the sales agreement, it does not specify what condition the devices were sold as, except that they were sold at a price of 10x the cost of comparable devices. My mother and i recognize that there are some risks involved with class i medical devices. But we question the fact that these devices had been used previously. We contacted the manufacturer for the information on the date of manufacture, which compared to the issuing date to determine how long these devices were in circulation. We received a letter from the manufacturer stating that they do repairs under warranty and do not take requests from consumers for repair. The devices have been sent back to (b)(6) at least 4x for repair and another time for cleaning. I have spoken over the phone with other companies and they have assured me that the repair times 4 is excessive because they have a tried method of testing for hearing devices.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077366
MDR Report Key7533908
Date Received2018-05-21
Date of Report2018-05-17
Date of Event2016-08-01
Date Added to Maude2018-05-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameMUSE I1600 WIRELESS
Generic NameHEARING AID, AIR CONDUCTION
Product CodeESD
Date Received2018-05-21
Model NumberMUSE I 1600 WIRELESS
Device Expiration Date2018-06-15
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSTARKEY LAB HEARING AID CO.

Device Sequence Number: 2

Brand NameMUSE I1600 WIRELESS
Generic NameHEARING AID, AIR CONDUCTION
Product CodeESD
Date Received2018-05-21
Model NumberMUSE I 1600 WIRELESS
Device Expiration Date2018-06-15
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerSTARKEY LAB HEARING AID CO.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-05-21

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