FDA Adverse Event Malfunction Summary report: N

HEARING AID EARGO

MDR report key: 9104206 · Received September 20, 2019

Report

Report Number
MW5089951
Event Type
Malfunction
Date Received
September 20, 2019
Date of Event
March 5, 2019
Report Date
September 18, 2019
Manufacturer
EARGO, INC.
Product Code
ESD
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I BOUGHT HEARING AID FROM EARGO ON (B)(6) 2019 AND SOMETIME BEGINNING OF (B)(6) STARTED EXPERIENCING PROBLEMS. CALLED THE COMPANY AND WAS OFFERED A REPLACEMENT. WHILE OFFERING A REPLACEMENT, THE COMPANY DID NOT NOTIFY ME IF THE REPLACEMENT WAS A NEW DEVICE OR A REFURBISHED ONE. IT WAS DURING THE TRIAL PERIOD OF 45 DAYS, SO IF I KNEW IT WAS A REFURBISHED ONE, I WOULD DEFINITELY REFUSE THE REPLACEMENT AND RETURN THE DEVICE. SO, I GOT THE REPLACEMENT THAT WORKED UNTIL (B)(6), THEN THE PROBLEMS STARTED GAIN. CALLED THE COMPANY AND WAS OFFERED ANOTHER REPLACEMENT, BUT BECAUSE THE REPLACEMENT ORDER COULD NOT BE COMPLETED ON TIME (BACK ORDER) I WAS OFFERED A NEW SYSTEM REPLACEMENT, I AGREED TO THE OFFER. THEN 30 MIN LATER THE REP CALLED AND SAID THAT THEY WILL NOT SEND ME THE NEW SYSTEM, BUT WILL FULFILL THE REPLACEMENT ORDER. THIS WAS WHEN I REALIZED THAT THE COMPANY IS SENDING ME THE REFURBISHED DEVICES. THE COMPANY'S RULE SAYS THAT THE REPLACEMENT CAN BE NEW OR REFURBISHED BASED ON COMPANY'S DISCRETION, BUT AS A CUSTOMER I HAVE NO IDEA WHAT IS THIS DISCRETION AND WHEN THE COMPANY WILL USE IT. NOT TELLING THE TRUTH TO A CUSTOMER IS LYING TO THE CUSTOMER. AND USING THE REFURBISHED MEDICAL DEVICE THAT YOU INSERT IN YOUR BODY PART IS GROSS. THE COMPANY SAYS THE DEVICE IS SANITIZED, BUT WHERE IS THE GUARANTEE? WHAT HAPPENS IF THE DEVICE BELONGED TO A CUSTOMER WITH SOME KIND OF VIRAL INFECTION OR OTHER MEDICAL ISSUES? BLAMED THE COMPANY FOR NOT TELLING THE TRUTH, ESPECIALLY WHEN THE TRIAL PERIOD WAS STILL ON AND I COULD'VE RETURN THE PRODUCT. I WANT A REFUND FOR MY (B)(6) BECAUSE THE PRODUCT THAT WAS ADVERTISED AS TOP OF THE LINE TECHNOLOGY HAD SO MANY ISSUES AND IS UNRELIABLE. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
895162 HEARING AID EARGO HEARING AID, AIR CONDUCTION ESD EARGO, INC.

Patients

Seq Age Sex Outcome Treatment
1 66 YR