MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-17 for DURACLIP HEMOCLIP, 235CM, 16MM DC0235W manufactured by Micro-tech(nanjing) Co.,ltd.
| Report Number | 3004837686-2020-00004 |
| MDR Report Key | 9838957 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-17 |
| 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 | BECKY LI |
| Manufacturer Street | NO.10 GAOKE THIRD ROAD NANJING NATIONAL HI-TECH, INDU |
| Manufacturer City | NANJING, JIANGSU 210032 |
| Manufacturer Country | CH |
| Manufacturer Postal | 210032 |
| Manufacturer G1 | MICRO-TECH(NANJING) CO.,LTD |
| Manufacturer Street | NO.10 GAOKE THIRD ROAD NANJING NATIONAL HI-TECH, INDU |
| Manufacturer City | NANJING, JIANGSU 210032 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 210032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURACLIP HEMOCLIP, 235CM, 16MM |
| Generic Name | HEMOSTATIC METAL CLIP FOR THE GI TRACT |
| Product Code | PKL |
| Date Received | 2020-03-17 |
| Catalog Number | DC0235W |
| Lot Number | M191009231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO-TECH(NANJING) CO.,LTD |
| Manufacturer Address | NO.10 GAOKE THIRD ROAD NANJING NATIONAL HI-TECH, INDU NANJING, JIANGSU 210032 CH 210032 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |