MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-06-14 for NITI-S PYLORIC & DUODENAL UNCOVERED STENT DXDT2210 manufactured by Taewoong Medical Co.,ltd..
| Report Number | 3003902943-2019-00022 |
| MDR Report Key | 8698576 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-06-14 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-05-17 |
| Device Manufacturer Date | 2019-01-24 |
| Date Added to Maude | 2019-06-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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, 10022 |
| Manufacturer Country | KS |
| Manufacturer Postal | 10022 |
| Manufacturer G1 | TAEWOONG MEDICAL CO.,LTD. |
| Manufacturer Street | 14, GOJEONG-RO WOLGOT-MYEON |
| Manufacturer City | GIMPO-SI, 10022 |
| Manufacturer Country | KS |
| Manufacturer Postal Code | 10022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NITI-S PYLORIC & DUODENAL UNCOVERED STENT |
| Generic Name | PYLORIC & DUODENAL STENT |
| Product Code | MUM |
| Date Received | 2019-06-14 |
| Model Number | DXDT2210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAEWOONG MEDICAL CO.,LTD. |
| Manufacturer Address | 14, GOJEONG-RO WOLGOT-MYEON GIMPO-SI, 10022 KS 10022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2019-06-14 |