FDA Adverse Event Injury Summary report: N

NANO-CIC-RECHARGE-JH-R/B

MDR report key: 16086067 · Received December 30, 2022

Report

Report Number
MW5114112
Event Type
Injury
Date Received
December 30, 2022
Report Date
December 28, 2022
Manufacturer
NANO HEARING TECH OPCO, LLC
Product Code
QUF
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MN, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

WE PURCHASED NANO HEARING AIDS ON (B)(6) 2022 RECEIVED THEM (B)(6) 2022. WE ARE RETIRED AND MY HUSBAND WANTED TO TRY THESE BASED ON COMMERCIALS AND THE FACT THEY ADVERTISED 45 DAY FULL REFUND IF NOT COMPLETELY SATISFIED. THEY DID NOT HELP HIS HEARING ONE BIT. HE ONLY WORE THEM TWICE. I GOT AN RA# FROM NANO RMA: (B)(4), BOXED THEM EXACTLY LIKE WE GOT THEM, SAME CONTAINER, BOX, ALL BOOKLETS, ACCESSORIES. WE SEND THEM BACK AND HEARD NO WORD FROM THEM AT ALL. AFTER I STARTED EMAILING THEM THEY TOLD ME THAT THE LEFT ONE WAS RECEIVED DAMAGED AND WE WOULD NOT BE GETTING BACK OUR (B)(6) (INCLUDES TAX) ACTUAL PRICE WAS (B)(6). THEY ACCUSED ME OF DAMAGING THEM. THEY WERE NOT DAMAGED! THEY WERE IN PERFECT CONDITION, HE AGAIN ONLY WORE THEM TWICE. I BELIEVE THEY DAMAGED THEM PURPOSELY SO THEY DON'T HAVE TO RETURN THE MONEY. WE DID NOTHING TO DAMAGE THEM. I FILED A COMPLAINT WITH THE BBB, THEY THEN TOLD THE BBB THE SAME LIE ABOUT BEING DAMAGED AND THEY OFFERED US ANOTHER PAID. THE FIRST PAIR DIDN'T WORK, WHY WOULD I WANT ANOTHER PAIR? THEN ON (B)(6) 2022 I FILED A COMPLAINT WITH THE (B)(6) OFFICE OF ATTORNEY GENERAL (B)(6) AND THEY STRONGLY SUGGESTED WE ALSO FILE A COMPLAINT WITH THE FDA, (B)(6) DEPT OF HEALTH AND FEDERAL TRADE COMMISSION. THIS COMPANY IS FALSELY ADVERTISING THEIR PRODUCT. THEY CLAIM A FULL REFUND WITHIN 45 DAYS OF PURCHASE, I BELIEVE THEY INTENTIONALLY DAMAGED THE HEARING AIDS. THERE ARE MANY COMPLAINTS ON THIS COMPANY. NANO HEARING AIDS, (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2765926 NANO-CIC-RECHARGE-JH-R/B HEARING AID, AIR-CONDUCTION, OVER THE COUNTER QUF NANO HEARING TECH OPCO, LLC
2765927 NANO-CIC-RECHARGE-JH-R/B HEARING AID, AIR-CONDUCTION, OVER THE COUNTER QUF NANO HEARING TECH OPCO, LLC.

Patients

Seq Age Sex Outcome Treatment
1 68 YR Male