MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-04 for GORE? CARDIOFORM ASD OCCLUDER ASD37A manufactured by W.l. Gore & Associates.
| Report Number | 2017233-2020-00140 |
| MDR Report Key | 9787564 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-05 |
| Device Manufacturer Date | 2018-05-21 |
| Date Added to Maude | 2020-03-04 |
| 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 | MARCI STEWART |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | FLAGSTAFF AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | KENDRICK PEAK MPD B/P |
| Manufacturer Street | 4250 W. KILTIE LANE |
| Manufacturer City | FLAGSTAFF AZ 86005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE? CARDIOFORM ASD OCCLUDER |
| Generic Name | TRANSCATHETER, SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-04 |
| Model Number | ASD37A |
| Catalog Number | ASD37A |
| Lot Number | 18148321A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-04 |