RESA INSOLES
Received Oct 16, 2018 · Event occurred Oct 6, 2018
Report MW5080620 · MDR key 7974478
Device
Generic name
Insoles, Medical
Manufacturer
Resa Wearables, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR
- Numbness
- Numbness
Narrative
Description of Event or Problem
I PURCHASED INSOLE FROM A (B)(6) IN (B)(6) BECAUSE THE SALESPERSON INFORMED THERE'S AN ORTHOTIC MEDICAL DEVICE THAT WAS BETTER THAN THE ONE I WAS WEARING, AND I WOULD NOT NEED A PRESCRIPTION FOR IT. THEY STATED THEY WERE FDA APPROVED WHEN I ASKED THE YOUNG MAN. I TOOK THEM HOME AND TRIED FOR A WEEK AND MY FOOT BECAME NUMB. THE YOUNG MAN SAID THE SOFT INSOLE WAS FOR DIABETICS AND WOULD PREVENT NEUROPATHIC ISSUES IN MY FEET. I ONLY BOUGHT THEM BECAUSE OF THE CLAIMS MADE BY THE YOUNG MAN. I HAVE NOT FOUND ANY FDA INFO ABOUT THIS COMPANY. I THINK THEY ARE LYING ABOUT FDA APPROVAL AND TESTS BY THE FDA. I THINK THEY ARE SELLING A DANGEROUS PRODUCT. THE YOUNG MAN STATED IT WAS FDA TESTED AND APPROVED.