BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD SOFT MESH

    MDR report key: 3122562 · Received May 17, 2013

    Report

    Report Number
    1213643-2013-00217
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 20, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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 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 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 PTS' ATTORNEY: IT IS ALLEGED THAT ON (B)(6) 2009 THE PT WAS IMPLANTED WITH A BARD SOFT MESH DURING AN UNSPECIFIED PELVIC PROCEDURE. ATTORNEY REPORT ALLEGES PAIN, "PAIN AND SUFFERING", DISABILITY, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219745 BARD SOFT MESH Mesh, surgical, polymeric FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUTD0431

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Disability NI.