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 2020-03-17 for EVICEL DEVICE 1ML/2ML EVD0102 manufactured by Tel-hashomer.
| Report Number | 3003183625-2020-00003 |
| MDR Report Key | 9841422 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-17 |
| 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 | ANN GOLDBLATT |
| Manufacturer Street | P.F.I MDA BLOODBANK KIRYAT-ONO |
| Manufacturer City | KIRYAT-ONO 55000 |
| Manufacturer Country | IS |
| Manufacturer Postal | 55000 |
| Manufacturer Phone | 0732588570 |
| Manufacturer G1 | TEL-HASHOMER |
| Manufacturer Street | P.F.I MDA BLOODBANK TEL-HASHOMER HOSPITAL |
| Manufacturer City | KIRYAT-ONO 55000 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 55000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVICEL DEVICE 1ML/2ML |
| Generic Name | FIBRIN SEALANT PREPARATION DEVICE |
| Product Code | MZM |
| Date Received | 2020-03-17 |
| Catalog Number | EVD0102 |
| Lot Number | 18-0075 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEL-HASHOMER |
| Manufacturer Address | P.F.I MDA BLOODBANK KIRYAT-ONO KIRYAT-ONO 55000 IS 55000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |