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 2019-11-11 for EPOC HOST 2 JAPAN 10736390 manufactured by Epocal Inc..
| Report Number | 3002637618-2019-00118 |
| MDR Report Key | 9306240 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-11-11 |
| Date of Report | 2019-11-11 |
| Date of Event | 2019-10-16 |
| Date Mfgr Received | 2019-10-18 |
| Date Added to Maude | 2019-11-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FELIX AKINRINOLA |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 6107052212 |
| Manufacturer G1 | EPOCAL INC. |
| Manufacturer Street | 2060 WALKLEY ROAD |
| Manufacturer City | OTTAWA, K1G 3P5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K1G 3P5 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPOC HOST 2 JAPAN |
| Generic Name | EPOC BARCODE READER |
| Product Code | CGL |
| Date Received | 2019-11-11 |
| Catalog Number | 10736390 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EPOCAL INC. |
| Manufacturer Address | 2060 WALKLEY ROAD OTTAWA, K1G 3P5 CA K1G 3P5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-11 |