inforMED
MalfunctionOGQ

QGRIPS

Received May 7, 2021 · Event occurred May 2, 2021

Report MW5101260 · MDR key 11797237

Device

Generic name

Ear Irrigation Kit

Manufacturer

Unk

Product problems

  • Product Quality Problem

Patient

32 MO

  • Pain
  • Pain

Narrative

Description of Event or Problem

I HAVE PURCHASED AN EAR CLEANING DEVICE CALLED QGRIPS FROM THIS WEBSITE: HTTPS://QGRIPS-OFFICIAL.ORG/ THE WEBSITE SAYS THAT THE DEVICE IS SUITABLE FOR USERS OF ALL AGES AND IS SAFE TO USE, HOWEVER, THE DEVICE DOES NOT WORK AS MARKETED I.E., THE DEVICE DOES NOT FIT INTO ADULTS EAR AND WHEN I TRIED TO USE IT FOR MY CHILD, HE SAID THAT IT IS HURTFUL. ACCORDINGLY, I BELIEVE THIS DEVICE IS A MEDICAL DEVICE, HOWEVER, IT SEEMS THAT IT IS NOT SUITABLE FOR THE INTENDED PURPOSE. I THINK THE SELLER MIGHT NOT BE COMPLIANT WITH SAFETY AND EFFECTIVENESS REQUIREMENTS FOR SUCH TYPE OF DEVICES. (B)(6). FDA SAFETY REPORT ID # (B)(4).