BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTIGEN BARD COLLAGEN IMPLANT

    MDR report key: 5027707 · Received August 25, 2015

    Report

    Report Number
    1018233-2015-00311
    Event Type
    Injury
    Date Received
    August 25, 2015
    Report Date
    February 23, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    LNM
    PMA / PMN Number
    P900030 S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: UROLOGICAL APPLICATIONS. ADVERSE EVENTS ASSOCIATED WITH TREATMENT MAY INCLUDE BUT ARE NOT LIMITED TO: WORSENED INCONTINENCE; URINARY RETENTION; URINARY TRACT INFECTION; AND/OR LOCALIZED RESPONSES (INCLUDING SWELLING, ERYTHEMA, INDURATION, INFECTION, NECROSIS, ABSCESS FORMATION, AND/OR HYPERSENSITIVITY RESPONSE). SLIGHT DISCOMFORT AND MILD BLEEDING WILL PROBABLY OCCUR AT THE INJECTION SITE IMMEDIATELY FOLLOWING THE INJECTION PROCEDURE. IN THE CLINICAL EVALUATION, APPROXIMATELY 2% OF TREATED PATIENTS REPORTED PAIN AT THE INJECTION SITE OR INJECTION SITE INJURY. TRANSIENT GROSS HEMATURIA MAY OCCUR IMMEDIATELY FOLLOWING THE INJECTION PROCEDURE. IN THE CLINICAL EVALUATION OF CONTIGEN IMPLANT, POST-PROCEDURE HEMATURIA OCCURRED IN APPROXIMATELY 2% OF TREATED PATIENTS. THE PATIENT SHOULD BE TOLD TO REPORT INCREASING DISCOMFORT OR SWELLING TO THE PHYSICIAN. SUMMARY OF OTHER APPLICATIONS (DERMAL) IN DERMAL APPLICATIONS, SENSITIZATION REACTIONS TO INJECTABLE COLLAGEN IMPLANTS HAVE OCCURRED IN 1-2% OF TREATED PATIENTS. MOST REACTIONS HAVE BEEN OF A HYPERSENSITIVITY NATURE AND HAVE CONSISTED OF ERYTHEMA, SWELLING, INDURATION AND/OR URTICARIA AT IMPLANTATION SITES. OFTEN THESE REACTIONS HAVE OCCURRED FOLLOWING AN UNRECOGNIZED OR UNREPORTED POSITIVE COLLAGEN SKIN TEST. ON RARE OCCASIONS, ABSCESS FORMATION HAS OCCURRED AT COLLAGEN IMPLANTATION SITES. IN SOME CASES THESE REACTIONS HAVE BEEN ASSOCIATED WITH ELEVATED TITERS OF ANTI-BOVINE COLLAGEN ANTIBODIES, AND REACTIONS CAN BE MULTIPLE OR RECURRENT. PERSISTED FOR MORE THAN ONE YEAR. ALTHOUGH SEVERAL FORMS OF THERAPY (ANTIHISTAMINES, NSAIDS, ORAL, TOPICAL, AND INTRALESIONAL STEROIDS) HAVE BEEN TRIED, USUALLY THEY RESULTED IN ONLY TEMPORARY IMPROVEMENT. IN MOST CASES, TIME HAS PROVEN TO BE THE DETERMINING FACTOR IN THE RESOLUTION OF THESE REACTIONS. IN RARE INSTANCES, PATIENTS HAVE BEEN LEFT WITH RESIDUAL FIRMNESS AT THE SITE OF A RESOLVED ADVERSE REACTION. (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. SAMPLE NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562026 CONTIGEN BARD COLLAGEN IMPLANT CONTIGEN BARD COLLAGEN IMPLANT LNM C.R. BARD, INC. (COVINGTON) -1018233 CVQK0010

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention