MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-25 for BACK BRACE L0650 manufactured by Optima Manufacturing, Llc..
[112441439]
(b)(6) charged me and insurance (b)(6) for a measly back brace. This is an over charge and they won't return it. It isn't even of good quality and they won't take it back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078063 |
| MDR Report Key | 7637915 |
| Date Received | 2018-06-25 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-05-15 |
| Date Added to Maude | 2018-06-26 |
| 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 | BACK BRACE |
| Generic Name | ORTHOSIS LIMB FOR BACK PAIN |
| Product Code | PMV |
| Date Received | 2018-06-25 |
| Model Number | L0650 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OPTIMA MANUFACTURING, LLC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-25 |