| Report Number | 3003902943-2020-00010 |
| MDR Report Key | 9691246 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-03 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-10-26 |
| Date Added to Maude | 2020-02-11 |
| 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 | MR. LEE |
| Manufacturer Street | 14, GOJEONG-RO WOLGOT-MYEON |
| Manufacturer City | GIMPO-SI, GYEONGGI-DO 10022 |
| Manufacturer Country | KS |
| Manufacturer Postal | 10022 |
| Manufacturer G1 | TAEWOONG MEDICAL CO.,LTD. |
| Manufacturer Street | 14, GOJEONG-RO WOLGOT-MYEON |
| Manufacturer City | GIMPO-SI, GYEONGGI-DO 10022 |
| Manufacturer Country | KS |
| Manufacturer Postal Code | 10022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |