MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-13 for VIONIC SHOES 335ADLEY/ASR-1437 OVC-A286564 manufactured by Vionic.
[89451938]
I purchased two pairs of vionic sneakers from (b)(6). On (b)(6) 2017 i tried them on to make sure i liked the fit. They did not feel right on my foot. I decided to wear them to the grocery - it would be quick and maybe could tell more about the shoes. I walked from the grocery store parking lot which is small and before i was half way into the store i had pain in my left ankle and my left knee popped, my right knee had terrible pain too but did not pop. I was hanging onto the shelving to not fall down which drew the attention from other shoppers. I needed help and rode an electric cart to my car. At this point it had not been 20 minutes since putting the shoes on at home. I had the man that makes custom prescription orthotics look at the shoes comparing them to another pair of vionic. Shoes i have. He concluded the shoes were one size smaller than marked and this put the arch support on the orthotic footbed to be located behind my arch causing my ankle/foot to rotate/roll to the outside of my body. The right shoe on both pairs were distorted in a twist causing the sole to wobble front to back. I saw a general practitioner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072743 |
| MDR Report Key | 6947538 |
| Date Received | 2017-10-13 |
| Date of Report | 2017-10-10 |
| Date of Event | 2017-01-19 |
| Date Added to Maude | 2017-10-13 |
| 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 | VIONIC SHOES |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KNP |
| Date Received | 2017-10-13 |
| Model Number | 335ADLEY/ASR-1437 |
| Catalog Number | OVC-A286564 |
| Lot Number | LC: 10-26-16 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VIONIC |
| Brand Name | VIONIC SHOES |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KNP |
| Date Received | 2017-10-13 |
| Model Number | 335ADLEY/ASR-1437 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | VIONIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-10-13 |