MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-13 for HEARTLIGHT 18-3356 manufactured by Cardiofocus.
| Report Number | 1225698-2020-00008 |
| MDR Report Key | 9831935 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2019-08-26 |
| Date Added to Maude | 2020-03-13 |
| 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. IAN CHRISTIANSON |
| Manufacturer Street | 500 NICKERSON RD. SUITE 500-200 |
| Manufacturer City | MARLBORO, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 6587231 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTLIGHT |
| Generic Name | HEARTLIGHT DEFLECTABLE SHEATH |
| Product Code | DRA |
| Date Received | 2020-03-13 |
| Model Number | 18-3356 |
| Catalog Number | 18-3356 |
| Lot Number | Q1656405 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOFOCUS |
| Manufacturer Address | 500 NICKERSON RD. SUITE 500-200 MARLBORO, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |