MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-05 for EVARREST FIBRIN SEALANT PATCH manufactured by Omrix Biopharmaceuticals Ltd.
[35553421]
This spontaneous report from a physician via a company 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 unspecified. The patient was treated with evarrest fibrin sealant patch initiated on an unspecified date for an unspecified indication. Concomitant medications were not reported. The physician mentioned that a colleague of his had experienced an infection after product use. He described it "as having a green color to it" (product physical issue). Action taken with evarrest fibrin sealant patch was unknown. The patient outcome for infection and product physical issue was unspecified. This report was serious (medically significant) and reportable (device malfunction). This case is linked to drug/device case (b)(4). A product quality complaint was associated with this report (reference number (b)(4)).
Patient Sequence No: 1, Text Type: D, B5
[36728392]
Additional information was received from the company representative on 12-jan-2016 and 14-jan-2016 in response to a query. The company representative reported that the event that the physician reported occurred in the past and was not his patient or his surgery. The physician's colleague mentioned it to him in passing. The representative did not believe that the patient's surgeon reported the events. The company representative also mentioned that based on the conversation in the room, the application of the product was to the liver, and the green substance was bile, but could not confirm this. A product quality investigation for product physical issue was not performed because no batch/lot number was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003183625-2015-01274 |
| MDR Report Key | 5345157 |
| Date Received | 2016-01-05 |
| Date of Report | 2015-12-08 |
| Date Mfgr Received | 2015-12-08 |
| Date Added to Maude | 2016-01-05 |
| 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 | LICENSE #1603, MDA BLOOD BANK SHEBA HOSPITAL |
| Manufacturer City | RAMAT GAN, 52621 |
| Manufacturer Country | IS |
| Manufacturer Postal | 52621 |
| Manufacturer Phone | 21532 |
| 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 | 2016-01-05 |
| 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 | M.D.A BLOOD BAND TEL HASHOMER, IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-05 |