FDA Adverse Event Malfunction Summary report: N

OLIVE MAX

MDR report key: 17372499 · Received July 20, 2023

Report

Report Number
MW5119794
Event Type
Malfunction
Date Received
July 20, 2023
Date of Event
April 3, 2023
Report Date
July 15, 2023
Manufacturer
OLIVE UNION INC.
Product Code
QUG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NV, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

MY HEARING AIDS WERE PURCHASED OVER A YEAR AS PART OF A CROWD FUNDING PROJECT. BELOW YOU WILL SEE THE STORY. THIS HAS ALSO BEEN SENT TO THE BBB(BETTER BUSINESS BUREAU), AG (ATTORNEY GENERAL) OF NEVADA, AND THE FTC (FEDERAL TRADE COMMISSION), AG OF NAVADA, AND THE FTC. OLIVE MAX HEARING AIDS WERE PURCHASED 4/5/2022 FOR 299.00+19.00 SHIPPING WITH THE UNDERSTANDING THAT THEY WOULD BE DELIVERED NOV 2022, THEN DEC 2022, AND FINALLY RECEIVED 3/28/23, DHL#(B)(6). ON THE SIXTH DAY I HAD PROBLEMS AND EMAILED WITH MY CONCERNS. WENT BACK AND FORTH AND ON MAY 12 THE CONCLUSION WAS TO SEND THEM BACK. DHL#(B)(6). THEY WERE RECEIVED ON MAY 18. MAY 24 OLIVE UNION CONFIRMED RECEIPT AND SAID REPLACEMENTS WOULD BE SENT ON MAY 25. JUNE 1 ASKED FOR AN UPDATE-NO RESPONSE. JUNE 12 ASKED FOR AN UPDATE- NO RESPONSE. JUNE 20 SENT CERTIFIED MAIL/RETURN RECEIPT #(B)(4) TO (B)(6) (BUSINESS MANAGER USA) WE HAD A FEW EMAILS THEN HE STOPPED COMMUNICATING. NO RESPONSE SINCE JUNE26. I HAD THESE HEARING AIDS APPOX. 45 DAYS. OLIVE UNION HAS HAD THEM APPOX. 55 DAYS AND COUNTING. I DON'T WANT THEM, I WANT MY MONEY BACK. THIS COMPANY CAN NOT BE TRUSTED. NO COMMUNICATION, NO PRODUCT, NO MONEY = SCAM. THIS IS WHERE THEY WERE PURCHASED. HTTPS://WWW.INDIEGOGO.COM/PROJECTS/OLIVEMAX-3-IN-1-HEARING-AID-EARBUD-TINNITUS-APP IF YOU SCROLL DOWN JUST PASS (MAKE A CONTRIBUTION) AND ON THE RIGHT CLICK " DISCUSSIONS" YOU WILL SEE I AM NOT THE ONLY ONE WITH ISSUES. HOPE THIS CAN BE RESOLVED. THANK YOU FOR YOUR TIME. (B)(6) I HAVE THE EMAIL THREAD BUT THERE IS NOT ENOUGH ROOM HERE TO PROVIDE THEM. HERE IS A FEW TO MAKE THE POINT. ON "06/01" ACCORDING TO YOUR EMAIL BELOW MY HEARING AIDS WERE SUPPOSED TO BE SENT ON "5/25". I HAVE YET TO RECEIVE THEM OR ANY TRACKING INFORMATION. COULD YOU PLEASE GIVE ME AN UPDATE. THANK YOU. ON "06/12" HAVE NOT HEARD FROM YOU IN 2WKS. I'M FEELING PRETTY DISCOURAGED. WITH NO RESPONSE YOU'RE LEAVING ME TO MY OWN THOUGHTS, WHICH ARE NOT VERY GOOD FOR YOU. ON MONDAY JUNE 19TH I WILL HAVE NO CHOICE BUT TO TAKE THIS TO THE NEXT LEVEL. PLEASE COMMUNICATE WITH ME. EITHER PROVIDE MY HEARING AIDS AS PROMISED OR REFUND MY MONEY. LOOKING FORWARD TO YOUR RESPONSE. ON "06/19" MR. (B)(6), (BUSINESS MANAGER USA) MY APOLOGIES FOR HAVING TO BRING THIS TO YOUR ATTENTION. MY NAME IS (B)(6). I REALLY WANTED TO LIKE THE OLIVE MAX. DUE TO THE CIRCUMSTANCES I DON'T FEEL COMFORTABLE WITH YOUR COMPANY ANYMORE. ATTACHED IS A PARTIAL THREAD OF MY COMMUNICATIONS WITH YOUR SUPPORT TEAM. AS YOU CAN SEE THERE HAS BEEN NO SUPPORT AND NO PRODUCT. AT THIS TIME I AM REQUESTING A REFUND. THANK YOU FOR YOUR TIME. I AM LOOKING FORWARD TO YOUR TIMELY RESPONSE. ON "06/26" UNFORTUNATELY, I CAN'T GUARANTEE YOU A REFUND AS OUR POLICY ON THE INDIEGOGO FAQ STATES NO REFUNDS AFTER DELIVERY. I UNDERSTAND YOU HAVE BEEN WAITING FOR A REPLY AND ARE UNHAPPY WITH THE SERVICE, AND I ONCE AGAIN APOLOGIZE. ON "06/26" I UNDERSTAND YOUR NO REFUND POLICY. AS FAR AS I AM CONCERNED I HAVE NOT RECEIVED THEM. YOU TOOK THEM BACK OVER A MONTH AGO THEN REFUSED TO COMMUNICATE WITH ME I DON'T FEEL THAT THE "NO REFUND POLICY APPLIES". AS I HAVE STATED I AM NOT COMFORTABLE DOING BUSINESS WITH YOU. I CANNOT TRUST YOUR SUPPORT TEAM TO BACK UP THE PRODUCT. I'M LOOKING FORWARD TO A FULL REFUND IN A TIMELY MANNER. IF YOU THINK I AM BEING UNREASONABLE PLEASE LET ME KNOW. WHAT WOULD YOU DO IF IT WERE YOU? THIS HOLE SITUATION HAS BEEN KEPT IN HOUSE, I PREFER TO KEEP IT THIS WAY. ON JULY 10 WHICH IS PLENTY OF TIME, I WILL BE SHARING MY INFORMATION WITH THE LOCAL BBB, THE NEVADA STATE ATTORNEY GENERALS OFFICE AND THE FEDERAL TRADE COMMISSION. I WILL LET THESE AGENCIES SORT THIS UNFORTUNATE SITUATION OUT. I HAVE ALL EMAILS AVAILABLE. THIS PRODUCT IS NOT READY FOR THE CONSUMER (DISCUSSIONS) ON THERE WEBSITE. THEY DO NOT COMMUNICATE OR SUPPORT THERE PRODUCT. THERE LAST EMAIL (07/14) STATES BE PATIENT WE WILL SEND THEM SOON. THEY HAVE DISMISSED MY NUMEROUS REQUESTS FOR A REFUND. REF REPORT: MW5119795.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
771871 OLIVE MAX HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, OVER THE COUNTER QUG OLIVE UNION INC.

Patients

Seq Age Sex Outcome Treatment
1 66 YR Male