BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - DULEX

    MDR report key: 5580504 · Received April 15, 2016

    Report

    Report Number
    1213643-2016-00143
    Event Type
    Injury
    Date Received
    April 15, 2016
    Report Date
    March 21, 2016
    Manufacturer
    BRIDGER BIOMED, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 WERE LIMITED TO THE PATIENT'S IMPLANT OPERATIVE REPORT AND IMPLANT TRACKING LOG. 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. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF LIMITED MEDICAL RECORDS AND THE ATTORNEY'S LEGAL CLAIM PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH SEVERE ANTERIOR AND CERVICAL CUFF PELVIC PROLAPSE AND STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT A TRANSABDOMINAL COLPOSACRAL FIXATION WITH IMPLANT OF A BARD/DAVOL DULEX MESH, ANTERIOR BLADDER NECK SUSPENSION WITH IMPLANT OF A NON BARD/DAVOL "SURGIPRO" MESH FOR BLADDER NECK SUSPENSION AND CYSTOSCOPY. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME ASSOCIATED T THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236739 MESH - DULEX SURGICAL MESH FTL BRIDGER BIOMED, INC. BRSH6220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other