MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-17 for SCEPTER MINI 2X10 MM BC0210M manufactured by Microvention, Inc..
| Report Number | 2032493-2020-00016 |
| MDR Report Key | 9604617 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-17 |
| Date of Report | 2019-12-18 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2019-07-02 |
| Date Added to Maude | 2020-01-17 |
| 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. MORGAN HOLODY |
| Manufacturer Street | 35 ENTERPRISE DRIVE |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCEPTER MINI 2X10 MM |
| Generic Name | OCCLUSION BALLOON CATHETER |
| Product Code | MJN |
| Date Received | 2020-01-17 |
| Returned To Mfg | 2020-01-02 |
| Model Number | BC0210M |
| Lot Number | 190702135 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROVENTION, INC. |
| Manufacturer Address | 35 ENTERPRISE DRIVE ALISO VIEJO CA 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |