BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3124061 · Received May 16, 2013

    Report

    Report Number
    1213643-2013-00214
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    April 30, 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
    MO, 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 CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO AND IF AVAILABLE, TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. 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 REC'D TO DATE. IF ADD'L EVENT AND/OR EVALUATION INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: IT WAS ALLEGED THAT ON (B)(6) 2009 THAT THE PT WAS IMPLANTED WITH A NON BARD IMPLANT TO TREAT A VAGINAL PROLAPSE. IT WAS ALLEGED THAT ON (B)(6) 2012 THE PT WAS IMPLANTED WITH A BARD FLAT MESH DURING AN UNSPECIFIED PELVIC PROCEDURE. ATTORNEY REPORT ALLEGES PERMANENT INJURY, NERVE DAMAGE, PAIN AND SUFFERING, ADD'L MEDICAL AND SURGICAL INTERVENTION, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216701 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUWB0252

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability