MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-12-26 for NITI-S PYLORIC & DUODENAL UNCOVERED STENT DDT2210 manufactured by Taewoong Medical Co.,ltd..
[131934329]
It was reported that, by seeing ct-image, it could be seen fractured at the center of the stent. It was impossible to review suspected device's dhr, because it was not confirmed serial no. Fracture can be occurred by other company's device as well as ours. It is affected by patient's lesion status, peristalsis of organs, and drug use in general. Duodenal structure where stent was implanted is curvy. Stent can be pressured due to patient's lesion status. However, it is hard to find out exact root cause for this complaint because the suspected device was not returned due to it was not removed from the patient, and it is difficult to reconstruct the situation at the time of procedure with limited information. This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analysis.
Patient Sequence No: 1, Text Type: N, H10
[131934330]
It was reported that the duodenal stent could be fractured. By seeing ct-image, it could be seen fractured at the center of the stent. The stent was placed about one year ago. No obstruction and problem with patient's condition and a scope can pass (with dementia). So it will be monitored how it goes. There were no patient complications as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003902943-2018-00035 |
| MDR Report Key | 8195046 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-12-07 |
| Date Mfgr Received | 2018-12-17 |
| Date Added to Maude | 2018-12-26 |
| 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. PARK |
| 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 |
| Brand Name | NITI-S PYLORIC & DUODENAL UNCOVERED STENT |
| Generic Name | PYLORIC & DUODENAL STENT |
| Product Code | MUM |
| Date Received | 2018-12-26 |
| Model Number | DDT2210 |
| 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, GYEONGGI-DO 10022 KS 10022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-26 |