BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3955207 · Received July 21, 2014

    Report

    Report Number
    1213643-2014-00247
    Event Type
    Injury
    Date Received
    July 21, 2014
    Report Date
    July 1, 2014
    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 UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT INJURY AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6), 1999 - THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL FLAT MESH DURING AN UNKNOWN PELVIC PROCEDURE. THE ATTORNEY'S REPORT ALLEGES PAIN, INJURY, "PAIN AND SUFFERING", DISABILITY, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426557 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43IJD273

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability