BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVARREST FIBRIN SEALANT PATCH

    MDR report key: 6242760 · Received January 11, 2017

    Report

    Report Number
    2210968-2016-01248
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Date of Event
    December 21, 2016
    Report Date
    January 26, 2017
    Manufacturer
    OMRIX BIOPHARMACEUTICALS LTD
    Product Code
    MZM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM (B)(6) ON (B)(6) 2017. ADDITIONAL BATCH NUMBER (BAC II FIBRINOGEN COMPONENT) T34C510 WAS ADDED. THE SUSPECTED PRODUCT QUALITY COMPLAINT (PQC) ASSOCIATED WITH ADVERSE EVENT LACK OF EFFICACY HAS BEEN CONFIRMED TO BE PRODUCT MEETS SPECIFICATIONS BASED ON THE PQC EVALUATION/INVESTIGATION PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM ETHICON QA (QUALITY ASSURANCE) ON (B)(6) 2017 AND FROM MSO (MEDICAL SAFETY OFFICER) ON (B)(6) 2017. ADDITIONAL BATCH NUMBER (B)(4) WAS ADDED. THE SUSPECTED PRODUCT QUALITY COMPLAINT (PQC) ASSOCIATED WITH ADVERSE EVENT LACK OF EFFICACY HAS BEEN CONFIRMED TO BE PRODUCT MEETS SPECIFICATIONS BASED ON THE PQC EVALUATION/INVESTIGATION PERFORMED.

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS REPORT FROM A PHYSICIAN VIA A SALES REPRESENTATIVE AND CONCERNS A PATIENT OF UNSPECIFIED AGE AND SEX FROM THE UNITED STATES: (B)(6). THE PATIENT'S HEIGHT, WEIGHT AND MEDICAL HISTORY WERE NOT REPORTED. THE PATIENT WAS TREATED WITH EVARREST FIBRIN SEALANT PATCH (BATCH T10F282A) INITIATED ON (B)(6) 2016 FOR HEMOSTASIS DURING AN OPEN ABDOMINAL AORTIC ANEURYSM. CONCOMITANT MEDICATIONS WERE NOT REPORTED. IT WAS REPORTED BY THE SALES REP THAT DURING AN OPEN ABDOMINAL AORTIC ANEURYSM REPAIR THAT SAME DATE, THE DEVICE DID NOT STOP THE BLEEDING (LACK OF EFFICACY). TWO SURGIFLO AND ONE SURGICEL WERE USED TO STOP THE BLEEDING AND COMPLETE THE PROCEDURE (BLEEDING). THE PATIENT RECEIVED AN UNSPECIFIED NUMBER OF TRANSFUSIONS (DETAILS UNSPECIFIED). IT IS UNKNOWN IF THERE WAS A CHANGE TO POST OPERATIVE CARE. ACTION TAKEN WITH EVARREST FIBRIN SEALANT PATCH WAS NOT APPLICABLE. THE PATIENT OUTCOME WAS UNKNOWN FOR LACK OF EFFICACY (SERIOUS) AND BLEEDING (SERIOUS). A PRODUCT QUALITY COMPLAINT IS ASSOCIATED WITH THIS REPORT. NO DEVICE WILL BE RETURNED. THIS REPORT WAS SERIOUS (MEDICALLY SIGNIFICANT) AND REPORTABLE (MALFUNCTION). THIS CASE IS LINKED TO DRUG/DEVICE CASE (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SALES REPRESENTATIVE ON (B)(6) 2016. THE CUSTOMER DID NOT ALLEGE THAT THERE WAS A DEFICIENCY WITH EITHER SURGIFLO OR SURGICEL. SURGICEL WAS USED THROUGHOUT THE PROCEDURE BEFORE AND AFTER USE OF FIBRIN SEALANT PATCH. THE FIBRIN SEALANT PATCH WAS USED WITH SURGICEL CREATE HEMOSTASIS ON THE AORTA. THE CURRENT STATUS MEDICAL HISTORY AND DEMOGRAPHICS OF THE PATIENT WERE UNKNOWN, BUT IT WAS REPORTED THAT THE PATIENT WAS ON PLAVIX (CLOPIDOGREL BISULFATE) DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27363 EVARREST FIBRIN SEALANT PATCH OTHER MZM OMRIX BIOPHARMACEUTICALS LTD T10F282A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other