MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-25 for RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM 28-M332095322290U manufactured by Bolton Medical, Inc..
| Report Number | 2247858-2020-00013 |
| MDR Report Key | 9880240 |
| Report Source | FOREIGN |
| Date Received | 2020-03-25 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2018-12-14 |
| Date Added to Maude | 2020-03-25 |
| 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. MEGAN INDEGLIA |
| Manufacturer Street | 799 INTERNATIONAL PARKWAY |
| Manufacturer City | SUNRISE, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 8389699 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM |
| Generic Name | STENT, ENDOVASCUALR GRAFT, AORTIC |
| Product Code | MIH |
| Date Received | 2020-03-25 |
| Catalog Number | 28-M332095322290U |
| Lot Number | J181218170 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOLTON MEDICAL, INC. |
| Manufacturer Address | 799 INTERNATIONAL PARKWAY SUNRISE, FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-25 |