MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-17 for REGARD 800747 manufactured by Resource Optimization & Innovation Llc.
[108723601]
A small particle was noted on a 4x4 gauze, while setting up the sterile field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077282 |
| MDR Report Key | 7525334 |
| Date Received | 2018-05-17 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-05-14 |
| Date Added to Maude | 2018-05-18 |
| 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 | 3 |
| Brand Name | REGARD |
| Generic Name | HT0952-CORONARY RADIAL |
| Product Code | OES |
| Date Received | 2018-05-17 |
| Returned To Mfg | 2018-05-15 |
| Catalog Number | 800747 |
| Lot Number | 051082 |
| Device Expiration Date | 2019-12-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESOURCE OPTIMIZATION & INNOVATION LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-17 |