BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTIGEN BARD COLLAGEN IMPLANT

    MDR report key: 2503072 · Received March 21, 2012

    Report

    Report Number
    1018233-2012-00261
    Event Type
    Injury
    Date Received
    March 21, 2012
    Report Date
    February 20, 2012
    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 DEVICE REMAINS IMPLANTED. 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: "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).

    Description of Event or Problem · 1

    AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, AND HAS SUSTAINED PERMANENT INJURY AND SUBSTANTIAL PHYSICAL DEFORMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTIGEN BARD COLLAGEN IMPLANT LNM C.R. BARD, INC. (COVINGTON) NA CVT00012

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention AVAULTA PLUS POSTERIOR SUPPORT SYSTEM