BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 2961949 · Received February 14, 2013

    Report

    Report Number
    2032282-2013-00020
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 5, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER SYNOVIS COMPLETED THE INVESTIGATION. NO SAMPLE WAS AVAILABLE HOWEVER, COMPLAINT WAS CONFIRMED BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. A BATCH REVIEW WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. BAXTER SYNOVIS INDICATED THAT FROM THE REVIEW OF THE SHELF-LIFE TESTING, THEY USE POST-STERILIZATION AS DAY ZERO OF THE TESTING. THE PRODUCT CAN BE USED ONE DAY AFTER EXPIRATION AND IT WILL NOT HAVE AN ADVERSE EFFECT. THE LABELING ON THE CARTONS AND OUTER POUCHES FOR VERITAS IS CLEARLY LABELED WITH THE EXPIRATION DATE. THE EXPIRATION DATE IS DEFINED AS 36 MONTHS AFTER THE WORK ORDER RELEASE DATE. BAXTER SYNOVIS CONCLUSIVELY DETERMINED THE COMPLAINT WAS DUE TO A USE ERROR IN WHICH THE CUSTOMER FAILED TO VERIFY THE EXPIRATION DATE OF THE PRODUCT PRIOR TO USE. THIS IS THE FIRST REPORTED COMPLAINT OF THIS NATURE FOR THIS PRODUCT LOT. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT USED WAS PAST ITS LABELED EXPIRATION DATE. ALTHOUGH UNLIKELY IN THIS CASE, RISKS OF USING PRODUCTS PAST ITS EXPIRATION DATE INCLUDE LOSS OF PRODUCT FUNCTION AS WELL AS LOSS OF STERILITY. AS NO INJURY OR INFECTION WAS REPORTED THIS RISK CAN BE RULED OUT. VERITAS COLLAGEN MATRIX ALLOWS FOR NEO-COLLAGEN FORMATION AND NEOVASCULARIZATION OF THE IMPLANTED DEVICE AND PERMITS REPLACEMENT OR REMODELING OF THE DEVICE WITH HOST TISSUE. ANY IMPACT ON THIS PROCESS OF REMODELING OR LOSS OF EXPECTED PRODUCT PERFORMANCE CAN'T BE ASSESSED IMMEDIATELY AFTER THE SURGICAL PROCEDURE AS THE DURATION OF THIS PROCESS IS VARIABLE UP TO SEVERAL WEEKS. USE OF PRODUCT PAST ITS CLEARLY LABELED EXPIRATION DATE IS OUT OF CONTROL OF THE MANUFACTURER. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF THE INVESTIGATION RESULTS OF THE SAMPLE.

    Description of Event or Problem · 1

    BAXTER SALES REPRESENTATIVE CALLED ON BEHALF OF THE CUSTOMER. DOCTOR HAD 2 PIECES OF VERITAS THAT EXPIRED ON (B)(6) 2013. HE USED ONE PIECE ON (B)(6) 2013, WITH NO ADVERSE AFFECTS NOTED AS OF YET WITH THE PATIENT. CUSTOMER HAS ONE PIECE TO RETURN. NO PATIENT OR USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65248 VERITAS COLLAGEN MATRIX MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS 5767164-1303776

    Patients

    Seq Age Sex Outcome Treatment
    1