MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-09 for ASAHI-INTECC AG141002 manufactured by Asahi Intecc Co., Ltd..
| Report Number | 3004718255-2019-00003 |
| MDR Report Key | 8772167 |
| Date Received | 2019-07-09 |
| Date of Report | 2019-07-08 |
| Report Date | 2019-07-08 |
| Date Reported to Mfgr | 2019-07-08 |
| Date Added to Maude | 2019-07-09 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ASAHI-INTECC |
| Generic Name | GRAND SLAM |
| Product Code | OUG |
| Date Received | 2019-07-09 |
| Returned To Mfg | 2019-06-18 |
| Catalog Number | AG141002 |
| Lot Number | 190130A071 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASAHI INTECC CO., LTD. |
| Manufacturer Address | 3-100 AKATSUKI-CHO SETO, AICHI, 4890071 JA 4890071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-09 |