MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for REGARD 800746 manufactured by Resource Optimization And Innovation Llc.
[107507335]
Was noted within the dressing gauze 4x4 16 ply, in the middle of the stack of 4x4's, brown in color particles x 2 were found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077006 |
| MDR Report Key | 7486212 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-04-27 |
| Date Added to Maude | 2018-05-04 |
| 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 | RISK MANAGER |
| 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 | REGARD |
| Generic Name | HT0951 - CORONARY FEMORAL |
| Product Code | OEQ |
| Date Received | 2018-05-03 |
| Returned To Mfg | 2018-04-27 |
| Catalog Number | 800746 |
| Lot Number | 049683 |
| Device Expiration Date | 2019-11-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESOURCE OPTIMIZATION AND INNOVATION LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-03 |