BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3964199 · Received July 11, 2014

    Report

    Report Number
    1213643-2014-00221
    Event Type
    Injury
    Date Received
    July 11, 2014
    Report Date
    June 17, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTY 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. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTY. ON (B)(6) 2001, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL FLAT MESH DURING A CYSTOSCOPY, URETHROLYSIS AND MESH SLING PLACEMENT PROCEDURE FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. THE ATTY'S REPORT ALLEGES PERMANENT INJURY, NERVE DAMAGE, PAIN AND SUFFERING, ADDITIONAL MEDICAL AND SURGICAL INTERVENTION, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407579 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43CLD071

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability