BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3252284 · Received July 22, 2013

    Report

    Report Number
    1213643-2013-00303
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 1, 2013
    Manufacturer
    DAVOL INC. SUB C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TOT HE REPORTED EVENT. THE PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVALUATION. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND IF AVAILABLE, TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF THE PT'S MEDICAL RECORDS WHICH WERE PROVIDED TO DAVOL BY THE PT'S ATTORNEY: (B)(6) 2009 - THE PT WAS IMPLANTED WITH A BARD MESH DEVICE. THE PT'S ATTORNEY ALLEGES PERMANENT INJURY, NERVE DAMAGE, PAIN AND SUFFERING, ADDITIONAL MEDICAL AND SURGICAL INTERVENTION, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339738 BARD FLAT MESH FTL DAVOL INC. SUB C.R. BARD, INC. NA HUSL0431

    Patients

    Seq Age Sex Outcome Treatment
    1