MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-20 for EVICEL APP DEVICE ACCESSORY TIP manufactured by Ethicon Inc..
| Report Number | 2210968-2019-87965 |
| MDR Report Key | 9101053 |
| Date Received | 2019-09-20 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-08-22 |
| Date Mfgr Received | 2019-08-22 |
| Date Added to Maude | 2019-09-20 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EVICEL APP DEVICE ACCESSORY TIP |
| Generic Name | FIBRIN SEALANT PREPARATION DEVICE |
| Product Code | MZM |
| Date Received | 2019-09-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-20 |