BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3041984 · Received April 1, 2013

    Report

    Report Number
    1213643-2013-00128
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    December 3, 2007
    Report Date
    March 6, 2013
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND, IF AVAILABLE, 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. THIS MDR INCLUDES ALL PATIENT, EVENT, AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2007- PATIENT IMPLANTED WITH A BARD FLAT MESH. ON (B)(6) 2007- PATIENT IMPLANTED WITH MULTIPLE NON-DAVOL PELVIC DEVICES. THE ATTORNEY'S REPORT ALLEGES PERMANENT INJURY, NERVE DAMAGE, PAIN AND SUFFERING, ADDITIONAL MEDICAL/SURGICAL INTERVENTION, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133139 BARD FLAT MESH FTL DAVOL INC. NA HURD2739

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability