BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 3882193 · Received June 18, 2014

    Report

    Report Number
    2032282-2014-00081
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    October 8, 2007
    Report Date
    May 29, 2014
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT SUMMARY: VERITAS COLLAGEN MATRIX IS INTENDED FOR USE IN RECONSTRUCTION OF THE PELVIC FLOOR EXCLUDING TRANSVAGINAL PELVIC ORGAN PROLAPSED AND FOR USE IN THE REPAIR OF RECTAL PROLAPSED EXCLUDING RECTOCELE. VERITAS COLLAGEN MATRIX IS NOT DESIGNED, SOLD, OR INTENDED FOR USE EXCEPT AS INDICATED; DOING SO MAY RESULT IN SURGICAL COMPLICATIONS. WHEN CLINICAL CIRCUMSTANCES REQUIRE IMPLANTATION IN A SITE THAT IS CONTAMINATED OR INFECTED, APPROPRIATE LOCAL AND/OR SYSTEMIC MEASURES SHOULD BE TAKEN TO MANAGE THE CONTAMINATION/INFECTION. AS WITH ANY SURGICAL PROCEDURE, ADVERSE REACTIONS ARE POSSIBLE AND INCLUDE BUT ARE NOT LIMITED TO: INFECTION, REJECTION, EROSION, AND ALLERGIC REACTION. THE LABELING OF THE MEDICAL DEVICE CAPTURES ACCURATELY THE POTENTIALS WARNINGS, RISKS AND HARMS RELATIVE TO THE USE OF VERITAS IN PELVIC FLOOR RECONSTRUCTION. GIVEN THAT THE LEGAL LETTER RECEIVED BY BAXTER SYNOVIS DOES NOT CONTAIN ANY DETAILS ON THE NATURE AND SEVERITY OF THE ¿INJURIES¿ CLAIMED, AND NO DESCRIPTION OF THE APPLICATION SITE OF THE MATRIX IS PROVIDED, A MEDICAL REVIEW OF A POTENTIAL CAUSAL RELATIONSHIP WITH THE USE OF VERITAS COLLAGEN MATRIX IS NOT POSSIBLE. FURTHER DETAILS REQUIRING INFORMATION ON SYMPTOMS AND COMPLICATIONS BEFORE FIRST SURGERY, AFTER FIRST SURGERY AND AFTER REVISION SURGERY ARE REQUIRED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION AND MANUFACTURER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER SYNOVIS COMPLETED THE INVESTIGATION. SAMPLE EVALUATION COULD NOT BE PERFORMED AS NO SAMPLE WAS AVAILABLE. BATCH REVIEW WAS PERFORMED AND PRODUCT MET SPECIFICATIONS; NO ISSUES WERE IDENTIFIED. NO TREND WAS IDENTIFIED. PER SYNOVIS, NO ADDITIONAL INVESTIGATION IS REQUIRED AT THIS TIME BECAUSE BASED ON THE DETAILS OF THE COMPLAINT, IT IS NOT EVIDENT THAT THE PRODUCT RESULTED IN THE PATIENT¿S ISSUES. NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. BAXTER LEGAL WILL HANDLE ALL CUSTOMER CONTACT AND NOTIFY GPS IF ANY ADDITIONAL INFORMATION IS RECEIVED. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    A PRODUCT LIABILITY LITIGATION WAS REPORTED TO BAXTER LEGAL IN REGARDS TO A PATIENT REPORTING A DEFECT AGAINST VERITAS COLLAGEN MATRIX. PATIENT¿S INITIALS: (B)(6); GENDER: FEMALE. AS REPORTED DATE OF IMPLANT OF VERITAS: (B)(6) 2007. (B)(6). BELOW IS A SUMMARY OF THE PLAINTIFF¿S COMPLAINTS: - FOLLOWING DESIGNATED PRODUCTS WERE IMPLANTED: O BOSTON SCIENTIFIC PRODUCT ¿ REPLIFORM (LOT#: B20376043); O SYNOVIS SURGICAL INNOVATIONS ¿ VERITAS COLLAGEN MATRIX 4X7 (LOT #: 5732280-624850); - IMPLANTATION OF PELVIC MESH OCCURRED ON (B)(6) 2007 AT (B)(6) HOSPITAL BY DR. (B)(6). PLANTIFF CLAIMS TO HAVE SUFFERED THE FOLLOWING INJURIES AS A RESULT OF IMPLANTATION OF THE PRIOR DESIGNATED PELVIC MESH PRODUCTS: MESH EROSION AND EXTRUSION, MESH EXPLANT SURGERY, MESH REJECTION, MULTIPLE INFECTIONS AND ABSCESSES REQUIRING NUMEROUS ROUNDS OF ANTIBIOTICS, PELVIC AND VAGINAL PAIN, URINARY AND BOWEL PROBLEMS, VAGINAL SCARRING, DISFIGUREMENT, DYSPAREUNIA, DEVELOPED AUTOIMMUNE DISORDER, CONTINUAL MEDICAL TREATMENT, ONGOING PAIN AND SUFFERING, AND EMOTION ANGUISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358662 VERITAS COLLAGEN MATRIX MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS 5732280-624850

    Patients

    Seq Age Sex Outcome Treatment
    1 Other