MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for MPO 2000 ACTIVE FOOT ORTHOSIS manufactured by Restorative Care Of America Inc..
[123353855]
I bought this mp0 2000 boot less than a year ago, from (b)(6), and it has cracked 3 times at the same place. This boot is dangerous. I contacted (b)(6) as (b)(6), but he sent me to deal with rcai the company that manufactures the product. I got nowhere with them. Rcai info restorative care of america, (b)(4); web:www. Rcai. Com. Date person started taking this product: (b)(6) 2018. Date the person stopped taking this product: (b)(6) 2018. Reason for use: to ease my heel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080417 |
| MDR Report Key | 7946995 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-09-26 |
| Date Added to Maude | 2018-10-09 |
| 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 | MPO 2000 ACTIVE FOOT ORTHOSIS |
| Generic Name | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT |
| Product Code | ISH |
| Date Received | 2018-10-05 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESTORATIVE CARE OF AMERICA INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2018-10-05 |