MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-29 for REGARD HT0951 manufactured by Resource Optimization & Innovation, L.l.c..
| Report Number | 8944307 |
| MDR Report Key | 8944307 |
| Date Received | 2019-08-29 |
| Date of Report | 2019-08-21 |
| Date of Event | 2019-01-23 |
| Report Date | 2019-08-21 |
| Date Reported to FDA | 2019-08-21 |
| Date Reported to Mfgr | 2019-08-29 |
| Date Added to Maude | 2019-08-29 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 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 | REGARD |
| Generic Name | CARDIAC CATHETERIZATION KIT |
| Product Code | OES |
| Date Received | 2019-08-29 |
| Model Number | HT0951 |
| Lot Number | 61049B |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESOURCE OPTIMIZATION & INNOVATION, L.L.C. |
| Manufacturer Address | 3000 E SAWYER RD REPUBLIC MO 65738 US 65738 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-29 |