MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-03 for REGARD HT00026L 880023012 manufactured by Roi Cps, Llc.
| Report Number | 3014527682-2020-00002 |
| MDR Report Key | 9780134 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-11-13 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MRS CHEYENNE STEWART |
| Manufacturer Street | 3000 EAST SAWYER ROAD |
| Manufacturer City | REPUBLIC MO 65738 |
| Manufacturer Country | US |
| Manufacturer Postal | 65738 |
| Manufacturer Phone | 4177303937 |
| Manufacturer G1 | ROI CPS, LLC |
| Manufacturer Street | 3000 EAST SAWYER ROAD |
| Manufacturer City | REPUBLIC MO 65738 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 65738 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REGARD |
| Generic Name | ANGIOGRAPHY DRAPE PACK |
| Product Code | OEQ |
| Date Received | 2020-03-03 |
| Model Number | HT00026L |
| Catalog Number | 880023012 |
| Lot Number | 73652L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROI CPS, LLC |
| Manufacturer Address | 3000 EAST SAWYER ROAD REPUBLIC MO 65738 US 65738 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |