BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 3092607 · Received May 3, 2013

    Report

    Report Number
    2032282-2013-00047
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 18, 2012
    Report Date
    April 18, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO THE LIMITED INFORMATION, THIS CASE IS CURRENTLY NOT ASSESSABLE AND BEING CONSERVATIVELY REPORTED. BAXTER IS CURRENTLY IN PROCESS IN RETRIEVING ADDITIONAL INFORMATION FROM THE CUSTOMER. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER CONTACT WAS MADE TO REQUEST ADDITIONAL INFORMATION. BAXTER WAS INFORMED THAT THE REPORTER IS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION AS THE ISSUE OCCURRED A LONG TIME AGO. DUE TO THE LACK OF INFORMATION A CAUSAL RELATIONSHIP CANNOT BE DETERMINED. BAXTER (B)(4) COMPLETED THE INVESTIGATION. NO SAMPLE AND LOT NUMBER WAS AVAILABLE THEREFORE SAMPLE EVALUATION AND BATCH REVIEW WERE NOT NECESSARY. PER (B)(4), BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE ROOT CAUSE CANNOT BE DETERMINED THUS THERE IS NO DIRECTION FOR FURTHER INVESTIGATION.NO TREND WAS IDENTIFIED FOR THIS PRODUCT COMPLAINT.THE COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER TERRITORY BUSINESS MANAGER (TBM) THAT WHEN SHE USED VERITAS, IT FORMED HERNIA SACKS. IT WAS STATED THIS EVENT OCCURRED A YEAR TO YEAR AND A HALF AGO. BAXTER TBM STATED THAT THE DOCTOR SEEMED CONFUSED ABOUT THE PRODUCT. HE ALSO STATED THAT SINCE IT OCCURRED SO LONG AGO, SHE MAY NOT HAVE ANY FURTHER INFORMATION, SUCH AS PATIENT IDENTIFIERS, ETC. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194101 VERITAS COLLAGEN MATRIX MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other