MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-31 for EVARREST FIBRIN SEALANT PATCH manufactured by Omrix Biopharmaceuticals, Ltd.
[53666529]
This spontaneous report from a other health professional concerns a male patient of unspecified age from the united states. The patient's weight and medical history were unknown. The patient was treated with evarrest fibrin sealant patch (batch (b)(4), expiry jul-2016). Initiated on (b)(6) 2016 for hemostasis. Concomitant medications were not reported. On (b)(6) 2016, the patient experienced expired product. The reporter stated that the subject was undergoing trauma sternotomy and lateral thoracotomy (for external trauma to the chest) for bleeding in the chest and an expired evarrest patch was used on a male patient. The patient survived the procedure and was in inpatient at the time of this report. Action taken with evarrest fibrin sealant patch was not applicable. The patient outcome was unknown for expired product. This report was not serious and reportable. This case is linked to drug/device (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2016-00888 |
| MDR Report Key | 5919472 |
| Date Received | 2016-08-31 |
| Date of Report | 2016-08-23 |
| Date Mfgr Received | 2016-08-23 |
| Date Added to Maude | 2016-08-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | US ROUTE 22 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082180707 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EVARREST FIBRIN SEALANT PATCH |
| Generic Name | EVARREST FIBRIN SEALANT PATCH |
| Product Code | MZM |
| Date Received | 2016-08-31 |
| Lot Number | T08F172A |
| Device Expiration Date | 2016-07-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMRIX BIOPHARMACEUTICALS, LTD |
| Manufacturer Address | M.D.A BLOOD BAND TEL HASHOMER, IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-31 |