MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-20 for VASC BAND 3524 manufactured by Lepu Medical Technology (beijing) Co.,ltd.
| Report Number | 3008002401-2020-00001 |
| MDR Report Key | 9735037 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-20 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-01-03 |
| Date Mfgr Received | 2020-03-25 |
| Date Added to Maude | 2020-02-20 |
| 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 | MS BO JIANG |
| Manufacturer Street | NO.37 CHAOQIAN ROAD, CHANGPING DISTRICT |
| Manufacturer City | BEIJING, 102200 |
| Manufacturer Country | CH |
| Manufacturer Postal | 102200 |
| Manufacturer G1 | LEPU MEDICAL TECHNOLOGY (BEIJING) CO.,LTD |
| Manufacturer Street | NO.37 CHAOQIAN ROAD, CHANGPING DISTRICT |
| Manufacturer City | BEIJING, 102200 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 102200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASC BAND |
| Generic Name | HEMOSTAT |
| Product Code | DXC |
| Date Received | 2020-02-20 |
| Returned To Mfg | 2020-01-17 |
| Model Number | 3524 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEPU MEDICAL TECHNOLOGY (BEIJING) CO.,LTD |
| Manufacturer Address | NO.37 CHAOQIAN ROAD, CHANGPING DISTRICT BEIJING, 102200 CH 102200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-20 |