MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-03-31 for ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM 3.5X20 LUN350R20IN manufactured by Medinol Ltd..
| Report Number | 3003084171-2020-00003 |
| MDR Report Key | 9902647 |
| Report Source | STUDY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-10-25 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-05-20 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MARINA DEMISHTEIN |
| Manufacturer Street | KIRYAT ATIDIM BLDG. 8 |
| Manufacturer City | TEL AVIV, 6158101 |
| Manufacturer Country | IS |
| Manufacturer Postal | 6158101 |
| Manufacturer G1 | MEDINOL LTD. |
| Manufacturer Street | BECK TECH BLDG 8 HARTOM ST. |
| Manufacturer City | JERUSALEM, JERUSALEM 9777508 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 9777508 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM |
| Generic Name | CORONARY DRUG-ELUTING STENT |
| Product Code | NIQ |
| Date Received | 2020-03-31 |
| Model Number | 3.5X20 |
| Catalog Number | LUN350R20IN |
| Lot Number | LNRIN00418 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDINOL LTD. |
| Manufacturer Address | BECK TECH BLDG 8 HARTOM ST. JERUSALEM, JERUSALEM 9777508 IS 9777508 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-31 |