BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3232251 · Received July 8, 2013

    Report

    Report Number
    1213643-2013-00292
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 21, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. WITHOUT A LOT NUMBER A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVAL. WE HAVE CONTACTED THE INITIAL REPORTER OR REQUEST ADD'L INFO. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE MADE. IF ADD'L 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. ON (B)(6) 2004, THE PT WAS IMPLANTED WITH AND UNK BARD FLAT MESH. ON (B)(6) 2007, THE PT WAS IMPLANTED WITH A NON-BARD DEVICE FOR A PELVIC REPAIR. THE ATTORNEY'S REPORT ALLEGES THAT THE PT HAS SUFFERED/WILL CONTINUE TO SUFFER PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, INABILITY TO ENGAGE IN CHOSEN AND NECESSARY ACTIVITIES AS A RESULT OF THE IMPLANTATION OF THE PRIOR DESIGNATED PELVIC MESH PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308965 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability