| Report Number | 9612392-2020-00004 |
| MDR Report Key | 9824290 |
| Report Source | CONSUMER |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-12 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PHARMACOVIGILANCE DEPT. |
| Manufacturer Street | MARUNOUCHI CENTER BUILDING 6-1, MARUNOUCHI 1-CHOME |
| Manufacturer City | CHIYODA-KU, TOKYO 100-0005 |
| Manufacturer Country | JA |
| Manufacturer Postal | 100-0005 |
| Manufacturer G1 | SEIKAGAKU CORPORATION - TAKAHAGI PLANT |
| Manufacturer Street | 258-5, AZA-MATSUKUBO OAZA-AKAHAMA |
| Manufacturer City | TAKAHAGI-SHI, IBARAKI 318-0001 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 318-0001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |