BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTIGEN BARD COLLAGEN TREATMENT SYRINGE

    MDR report key: 3213741 · Received July 3, 2013

    Report

    Report Number
    1018233-2013-02655
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 3, 2013
    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
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-02645 AND 1018233-2013-02658.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305978 CONTIGEN BARD COLLAGEN TREATMENT SYRINGE LNM C.R. BARD, INC. (COVINGTON) NA 03GN2009

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention BARD COLLAGEN: PRODUCT # 651005, LOT # 03GN2009