MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-16 for EVARREST FIBRIN SEALANT PATCH manufactured by Omrix Biopharmaceuticals Ltd.
[70328692]
This was a spontaneous report from a health professional via a sales representative and concerns a patient of unspecified age and sex from the united states: local case id number (b)(4). The patient's height, weight and medical history were not reported. The patient was treated with evarrest fibrin sealant patch (batch unknown) initiated on (b)(6) 2017 for hemostasis during liver donor procedure. Concomitant medications were not reported. On (b)(6) 2017, the patient experienced lack of efficacy. It was reported by the sales representative that during a liver donor procedure, lasting twenty hours, the evarrest fibrin sealant patch didn't achieve hemostasis when applied to the patient. Up to 100 units of blood was transfused throughout the procedure and other hemostatic agents were used to achieve hemostasis. There were no patient consequences reported. The product was discarded and won't be returned. Action taken with evarrest fibrin sealant patch was not applicable the patient outcome was recovered for lack of efficacy. This report was serious (medically significant), and reportable/not reportable (malfunction). This case is linked to drug/device case (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[71629245]
Additional information was received from ethicon on 20-mar-2017. A pqc (product quality complaint) investigation was not performed because no lot number was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2017-00192 |
| MDR Report Key | 6408879 |
| Date Received | 2017-03-16 |
| Date of Report | 2017-03-20 |
| Date of Event | 2017-02-28 |
| Date Mfgr Received | 2017-03-06 |
| Date Added to Maude | 2017-03-16 |
| 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 | 3 |
| Brand Name | EVARREST FIBRIN SEALANT PATCH |
| Generic Name | EVARREST FIBRIN SEALANT PATCH |
| Product Code | MZM |
| Date Received | 2017-03-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMRIX BIOPHARMACEUTICALS LTD |
| Manufacturer Address | TEL HASHOMER IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-16 |