MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for LOTUS INTRODUCER SET H749NTR200 LIS-L manufactured by Creganna Medical Also D.b.a Creganna Tactx Medical.
| Report Number | 3004193842-2020-00008 |
| MDR Report Key | 9903241 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-08-30 |
| 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 | MS. MAKO SUGIMURA |
| Manufacturer Street | PARKMORE WEST |
| Manufacturer City | GALWAY, H91 VN2T |
| Manufacturer Country | EI |
| Manufacturer Postal | H91 VN2T |
| Manufacturer G1 | CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL |
| Manufacturer Street | PARKMORE WEST |
| Manufacturer City | GALWAY, H91 VN2T |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91 VN2T |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOTUS INTRODUCER SET |
| Generic Name | INTRODUCER CATHETER |
| Product Code | DYB |
| Date Received | 2020-03-31 |
| Model Number | H749NTR200 |
| Catalog Number | LIS-L |
| Lot Number | 0000011151 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL |
| Manufacturer Address | PARKMORE WEST GALWAY, H91 VN2T EI H91 VN2T |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |