MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for REGARD HT0951 800746 manufactured by Resource Optimization And Innovation Llc.
[109062807]
A dark in color particle was noted on 4x4 gauze, while setting up the sterile field. Coronary femoral - (b)(6) health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077355 |
| MDR Report Key | 7533736 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-05-17 |
| Date Added to Maude | 2018-05-22 |
| 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 | CARDIAC CATHETERIZATION KIT |
| Product Code | OES |
| Date Received | 2018-05-21 |
| Model Number | HT0951 |
| Catalog Number | 800746 |
| Lot Number | 050678 |
| Device Expiration Date | 2019-12-07 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESOURCE OPTIMIZATION AND INNOVATION LLC |
| Manufacturer Address | PO BOX 505160 ST. LOUIS MO 631505160 US 631505160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-21 |