BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 2998259 · Received March 11, 2013

    Report

    Report Number
    2032282-2013-00030
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    July 23, 2008
    Report Date
    March 5, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER SYNOVIS COMPLETED THE INVESTIGATION. SAMPLE EVALUATION COULD NOT BE PERFORMED AS NO SAMPLE WAS AVAILABLE. BATCH RECORD REVIEW WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. PER SYNOVIS, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE ROOT CAUSE IS UNDETERMINABLE AT THIS TIME. BAXTER LEGAL HAS MADE MULTIPLE ATTEMPTS TO RETRIEVE ADDITIONAL CASE INFORMATION FROM THE PLAINTIFF'S LEGAL FIRM ((B)(4) FIRM). NO RESPONSE RECEIVED. BAXTER LEGAL ADVISED THAT NO FURTHER ACTION IS TO BE TAKEN AS THIS IS A POTENTIAL LITIGATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. THIS IS THE FIRST COMPLAINT OF THIS NATURE RECEIVED FOR THIS PRODUCT LOT. THE COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT SUMMARY: FOLLOWING THE IMPLANTATION OF TWO VERITAS COLLAGEN IMPLANTS FOR AN UNSPECIFIED SURGICAL INDICATION AND PATHOLOGY, A PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENT DYSPAREUNIA, AND NEUROMUSCULAR PROBLEMS. THE VERITAS COLLAGEN MATRIX IS A RE-ABSORBABLE COLLAGEN THAT ALLOWS FOR NEO-COLLAGEN FORMATION AND NEOVASCULARIZATION OF THE IMPLANTED DEVICE AND PERMITS REPLACEMENT OF THE DEVICE WITH HOST TISSUE, OR REMODELING. IN OTHER WORDS, THE ORIGINAL MATRIX REABSORBS AND IS REPLACES BY HOST TISSUE (SO THERE WILL BE NOTHING TO EVENTUALLY EXPLANTS). ALTHOUGH A CAUSAL RELATIONSHIP APPEARS UNLIKELY, BASED ON THE LACK OF CLINICAL INFORMATION A CAUSALITY ASSESSMENT IS YET NOT POSSIBLE. BAXTER HAS CONTACTED CALDERA AND WAS ADVISED THEY HAVE NO ADDITIONAL INFORMATION CONCERNING THE CASE AND THEY HAVE RECEIVED THIS FROM (B)(4) PER THE MEDWATCH. THE FIRM IS CURRENTLY FILING SUIT AGAINST CALDERA. BAXTER IS CURRENTLY FOLLOWING UP WITH (B)(4) FOR ADDITIONAL CASE DETAILS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON REVIEW OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS RECEIVED DIRECTLY FROM CALDERA: DATE OF EVENT AND IMPLANTED DATE: (B)(6) 2008. DATE OF USER FACILITY/IMPORTER BECAME AWARE OF EVENT: (B)(6) 2012. AN EVENT WAS REPORTED TO CALDERA MEDICAL BY AN ATTORNEY. LEGAL COMPLAINT STATES THAT A PATIENT SUFFERED PAIN, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE DYSPAREUNIA, AND NEUROMUSCULAR PROBLEMS IN WHICH 2 PRODUCTS WITH DIFFERENT LOT NUMBERS OF HYDRIX XM (CURRENTLY KNOWN AS VERITAS) WAS USED. NO ADDITIONAL INFORMATION PROVIDED. PLEASE REFER TO THE FOLLOWING COMPLAINTS FOR EACH PRODUCT LOT: (B)(4) FOR LOT#: 5740466-822804 ((B)(4), BAXTER'S MEDWATCH REPORT#: 2032282-2013-00029). (B)(4) FOR LOT#: 5741033-836952 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102291 VERITAS COLLAGEN MATRIX MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS 5741033-836952

    Patients

    Seq Age Sex Outcome Treatment
    1 Other