BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3122554 · Received May 17, 2013

    Report

    Report Number
    1213643-2013-00220
    Event Type
    Injury
    Date Received
    May 17, 2013
    Report Date
    April 24, 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
    VA, 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 ATTORNEY'S REPORT ALLEGES THAT IN 2012, THE PT WAS IMPLANTED WITH MULTIPLE PRODUCTS, INCLUDING A BARD FLAT MESH. NO SPECIFIC FAILURE MODE HAS BEEN ALLEGED AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, NO SAMPLE HAS BEEN RETURNED FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADD'L EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFO AS REPORTED BY THE PT'S ATTORNEY: ON (B)(6) 2012, PT WAS IMPLANTED WITH A BARD FLAT MESH AND OTHER NON-BARD IMPLANTS. ON (B)(6) 2012, PT IMPLANTED WITH A NON-BARD PRODUCT. ATTORNEYS REPORT ALLEGES PERMANENT INJURY, NERVE DAMAGE, PAIN AND SUFFERING, ADD'L MEDICAL AND SURGICAL INTERVENTION, AND DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218819 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUUI1785

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability