FDA Adverse Event Malfunction Summary report: N

MIRA FERTILITY PLUS WANDS

MDR report key: 11744596 · Received April 28, 2021

Report

Report Number: MW5101072
Event Type: Malfunction
Date Received: April 28, 2021
Date of Event: April 21, 2021
Report Date: April 27, 2021
Manufacturer: QUANOVATE TECH INC.
Product Code: QKE
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: CA, US
Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 1

FAILED FERTILITY TREATMENT; I'M DOING FERTILITY TREATMENTS AT MY FERTILITY CLINIC AND USING THE MIRA DEVICE AT HOME TO MONITOR MY CYCLE. I PURCHASED A BOX OF MIRA FERTILITY PLUS WANDS IN MARCH 2021 AND HAVE BEEN GETTING ERROR MESSAGES THAT THEY DIDN'T WORK. I REACHED OUT TO MIRA SUPPORT AND THEY TOLD ME THAT THERE IS A KNOWN ISSUE WITH THE LOT OF TESTS I GOT. BY THE TIME THEY RESPONDED, I WAS WELL INTO MY CYCLE AND MISSED MY FERTILE WINDOW. THIS CAUSED ME TO SPEND THOUSANDS OF DOLLARS ON MEDICATIONS WITHOUT CONCEPTION SINCE MIRA DEVICE TOLD ME I WAS NOT FERTILE BUT THE DOCTOR DID A BLOOD DRAW AND I HAD ALREADY PASSED MY FERTILE WINDOW. I'M NOT EXACTLY SURE WHY MIRA HAS A KNOWN ISSUE WITH THEIR PRODUCTS BUT IT STILL SELLING THEM. SHOULDN'T THEY BE RECALLED SINCE THEY DON'T WORK? I POSTED MY PROBLEM TO THEIR FACEBOOK SUPPORT GROUP AND 6 OTHER WOMEN HAD THE SAME PROBLEM AS ME. THIS COMPANY IS SELLING WORTHLESS PRODUCTS AND IT CAUSES WOMEN LIKE ME TO MISS OUR FERTILITY WINDOWS. THEY ARE VERY EXPENSIVE TOO. CAN ANYTHING BE DONE TO MAKE MIRA RECALL THEIR DEFECTIVE PRODUCT? FDA SAFETY REPORT ID # (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
632890	MIRA FERTILITY PLUS WANDS	IMMUNOASSAY, PREGNANEDIOL GLUCURONIDE, OVER THE COUNTER	QKE	QUANOVATE TECH INC.	MIRA FERTILITY PLUS WAND	2021010305
632891	READER	DEVICE, FERTILITY DIAGNOSTIC, PROCEPTIVE	LHD	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	32 YR		Other