MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-16 for RESA INSOLES manufactured by Resa Wearables, Inc..
[124136308]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080620 |
| MDR Report Key | 7974478 |
| Date Received | 2018-10-16 |
| Date of Report | 2018-10-13 |
| Date of Event | 2018-10-06 |
| Date Added to Maude | 2018-10-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RESA INSOLES |
| Generic Name | INSOLES, MEDICAL |
| Product Code | KYS |
| Date Received | 2018-10-16 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESA WEARABLES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-16 |