MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-19 for HEARTSPAN TRANSSEPTAL NEEDLE 00884450169704 FND-020-01 manufactured by Merit Medical Systems, Inc..
| Report Number | 2529252-2020-00005 |
| MDR Report Key | 9857537 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-19 |
| 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. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 W MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT |
| Manufacturer Country | US |
| Manufacturer Phone | 2084551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 65 GREAT VALLEY PARKWAY |
| Manufacturer City | MALVERN, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTSPAN TRANSSEPTAL NEEDLE |
| Generic Name | TRANSSEPTAL NEEDLE |
| Product Code | DRC |
| Date Received | 2020-03-19 |
| Model Number | 00884450169704 |
| Catalog Number | FND-020-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 65 GREAT VALLEY PARKWAY MALVERN, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |