MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-20 for EVICEL FIBRIN SEALANT 5ML-KIT 3905 manufactured by Tel-hashomer.
| Report Number | 3003183625-2019-00002 |
| MDR Report Key | 9348035 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-20 |
| Date of Report | 2019-10-24 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2019-10-24 |
| Date Added to Maude | 2019-11-20 |
| 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 | 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 FIBRIN SEALANT 5ML-KIT |
| Generic Name | FIBRIN SEALANT PREPARATION DEVICE |
| Product Code | MZM |
| Date Received | 2019-11-20 |
| Catalog Number | 3905 |
| Lot Number | 190077 |
| 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 TEL-HASHOM KIRYAT-ONO 55000 IS 55000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-20 |