BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 3854032 · Received June 6, 2014

    Report

    Report Number
    2032282-2014-00075
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 30, 2014
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: BASED ON THE INFORMATION RECEIVED IT APPEARS THAT AFTER IMPLANTATION OF THE VERITAS COLLAGEN MATRIX (TWO IMPLANTS), THE PATIENT DEVELOPED PERSISTENT SEROMA THAT REQUIRED SURGICAL REINTERVENTION WITH IMPLANT REMOVAL. WHILE IT IS NOT POSSIBLE TO DETERMINE WHETHER THE VERITAS COLLAGEN MATRIX ITSELF OR OTHER SURGERY (EXTENSIVE COAGULATION, TISSUE MANIPULATION, ASSOCIATED IMPLANTS, SUTURE MATERIAL) OR PATIENT RELATED FACTORS HAVE CAUSED THE INFLAMMATORY REACTION, WE CANNOT EXCLUDE THAT THE COLLAGEN IMPLANT HAS CAUSED OR CONTRIBUTED TO THE SEROMA FORMATION. BAXTER ITALY IS IN THE PROCESS OF FOLLOWING UP WITH THE PHYSICIAN FOR ADDITIONAL CASE INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER ITALY HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN AN EFFORT TO RETRIEVE ADDITIONAL INFORMATION. NO RESPONSE WAS RECEIVED. BAXTER SYNOVIS COMPLETED THE INVESTIGATION. SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED AS NO SAMPLE OR LOT NUMBER WERE PROVIDED. CAPA DETERMINATION WAS PERFORMED AND IT WAS DETERMINED NO CAPA IS NEEDED AT THIS TIME. NO TREND WAS IDENTIFIED AS PER CTT201404. PER SYNOVIS, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE ROOT CAUSE CANNOT BE DETERMINED THEREFORE DIRECTION FOR FURTHER INVESTIGATION IS NOT POSSIBLE. THIS COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER ITALY THAT THE CUSTOMER HAD 2 UNITS OF VERITAS REMOVED FROM A PATIENT AFTER 40 DAYS FROM THE IMPLANTATION DATE BECAUSE TOO MUCH SERUM WAS PRODUCED. THE DOCTOR SAID ALSO THAT HE DOESN'T HAVE MUCH EXPERIENCE WITH THIS TYPE OF IMPLANTATION AND MAYBE THE PATIENT WAS NOT SUITABLE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332086 VERITAS COLLAGEN MATRIX MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other