MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-07-08 for ASAHI CHIKAI 008 N/A WAIN-CKI-008-200 manufactured by Asahi Intecc Co., Ltd..
| Report Number | 3003775027-2019-00111 |
| MDR Report Key | 8770099 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-07-08 |
| Date of Report | 2019-07-09 |
| Date of Event | 2019-06-11 |
| Date Mfgr Received | 2019-06-18 |
| Device Manufacturer Date | 2019-03-05 |
| Date Added to Maude | 2019-07-08 |
| 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 | YUKAKO HOMMA |
| Manufacturer Street | 3-100 AKATSUKI-CHO |
| Manufacturer City | SETO, AICHI 489-0071 |
| Manufacturer Country | JA |
| Manufacturer Postal | 489-0071 |
| Manufacturer G1 | ASAHI INTECC CO., LTD. |
| Manufacturer Street | 3-100 AKATSUKI-CHO |
| Manufacturer City | SETO, 489-0071 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 489-0071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASAHI CHIKAI 008 |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2019-07-08 |
| Returned To Mfg | 2019-07-01 |
| Model Number | N/A |
| Catalog Number | WAIN-CKI-008-200 |
| Lot Number | 190222A30A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASAHI INTECC CO., LTD. |
| Manufacturer Address | 3-100 AKATSUKI-CHO SETO, 489-0071 JA 489-0071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-08 |