MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-10 for ORIGEN REINFORCED DUAL LUMEN CATHETER VV28F manufactured by Origen Biomedical, Inc.
| Report Number | 1646848-2020-00001 |
| MDR Report Key | 9574681 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-07 |
| Date of Event | 2016-11-23 |
| Date Mfgr Received | 2017-04-03 |
| Device Manufacturer Date | 2014-08-08 |
| Date Added to Maude | 2020-01-10 |
| 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 | MRS. KIERSTEN SODERMAN |
| Manufacturer Street | 7000 BURLESON RD. BLDG. D |
| Manufacturer City | AUSTIN TX 78744 |
| Manufacturer Country | US |
| Manufacturer Postal | 78744 |
| Manufacturer Phone | 5126157606 |
| Manufacturer G1 | ORIGEN BIOMEDICAL, INC |
| Manufacturer Street | 7000 BURLESON RD. BLDG. D |
| Manufacturer City | AUSTIN TX 78744 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78744 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0183-2019 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORIGEN REINFORCED DUAL LUMEN CATHETER |
| Generic Name | ECMO CANNULA |
| Product Code | DWF |
| Date Received | 2020-01-10 |
| Model Number | VV28F |
| Lot Number | N18487 |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORIGEN BIOMEDICAL, INC |
| Manufacturer Address | 7000 BURLESON RD. BLDG. D AUSTIN TX 78744 US 78744 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |