MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-15 for NITI-S ENTERAL COLONIC COVERED STENT CST2210F manufactured by Taewoong Medical Co.,ltd..
| Report Number | 3003902943-2020-00003 |
| MDR Report Key | 9589827 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-19 |
| Date Mfgr Received | 2019-12-19 |
| Device Manufacturer Date | 2019-07-19 |
| Date Added to Maude | 2020-01-15 |
| 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, 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 ENTERAL COLONIC COVERED STENT |
| Generic Name | COLONIC STENT |
| Product Code | MQR |
| Date Received | 2020-01-15 |
| Model Number | CST2210F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-15 |