MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for MIAMI OCCIAN JR. ACB-200 manufactured by Ossur Americas, Inc.
[117009932]
The occian jr? Back that is designed to fit the miami ]r? P2 & pl front doesn't actually fit the p1 appropriately. Consequently we don't use the p1 front since it does not provide stability and adequate skin protection for c-spine patients. This is a manufacturer design flaw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7780251 |
| MDR Report Key | 7780251 |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-08-08 |
| Report Date | 2018-08-08 |
| Date Reported to FDA | 2018-08-08 |
| Date Reported to Mfgr | 2018-08-14 |
| Date Added to Maude | 2018-08-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | MIAMI OCCIAN JR. |
| Generic Name | ORTHOSIS, CERVICAL |
| Product Code | IQK |
| Date Received | 2018-08-14 |
| Catalog Number | ACB-200 |
| Lot Number | MX170731 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR AMERICAS, INC |
| Manufacturer Address | 27051 TOWNE CENTRE DRIVE SUITE 100 FOOTHILL RANCH CA 92610 US 92610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-14 |