MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for RUNTHROUGH NS TW*AS418XA 25-1011 manufactured by Terumo Corporation, Ashitaka.
| Report Number | 2243441-2020-00019 |
| MDR Report Key | 9883600 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-26 |
| Date Facility Aware | 2020-03-03 |
| Report Date | 2020-03-26 |
| Date Reported to FDA | 2020-03-26 |
| Date Reported to Mfgr | 2020-03-05 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUNTHROUGH NS |
| Generic Name | WIRE, GUIDE, CATHETER |
| Product Code | DQX |
| Date Received | 2020-03-26 |
| Model Number | TW*AS418XA |
| Catalog Number | 25-1011 |
| Lot Number | UK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CORPORATION, ASHITAKA |
| Manufacturer Address | 150 MAIMAIGI-CHO FUJINOMIYA CITY, 418 JA 418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |