BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTIGEN COLLAGEN TREATMENT SYRINGE

    MDR report key: 3132841 · Received May 16, 2013

    Report

    Report Number
    1018233-2013-01766
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    November 17, 2015
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    LNM
    PMA / PMN Number
    P900030
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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)." (B)(4).

    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. ASSOCIATED MDRS: 1018233-2013-01765, 1018233-2013-01780, 1018233-2013-01964, 1018233-2013-01965, 1018233-2013-01966, AND 1018233-2013-01967. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218556 CONTIGEN COLLAGEN TREATMENT SYRINGE LNM C.R. BARD, INC. (COVINGTON) NA CVTA0012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention