BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3011071 · Received March 12, 2013

    Report

    Report Number
    1213643-2013-00094
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 15, 2010
    Report Date
    February 22, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE, HOWEVER, CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO AND IF AVAILABLE, TO REQUEST RETURN OF THE DEVICE FOR EVAL. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: (B)(6) 2010 - A BARD FLAT MESH WAS IMPLANTED INTO THE PT'S PELVIC AREA. THE ATTORNEY'S REPORT ALLEGES PERMANENT INJURY, NERVE DAMAGE, PAIN AND SUFFERING, ADDITIONAL MEDICAL/SURGICAL INTERVENTION, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104355 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUSL0435

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Disability