BEUDAMED
    FDA Adverse Event Other Summary report: N

    PELVITEX POLYPROPYLENE MESH

    MDR report key: 5900281 · Received August 24, 2016

    Report

    Report Number
    1018233-2013-00198
    Event Type
    Other
    Date Received
    August 24, 2016
    Report Date
    August 16, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11:SECTION A THROUGH F - 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 · 0

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00196.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, URINARY PROBLEMS DYSPAREUNIA BOWEL PROBLEMS AND BLEEDING.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED URINARY TRACT INFECTION, URETHRAL PAIN WITH/AFTER URINATION, ABDOMINAL PAIN, DISCHARGE AND LEUKOCYTES IN URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554501 PELVITEX POLYPROPYLENE MESH FTL SOFRADIM PRODUCTION NA PJC00738

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention ALIGN R RETROPUBIC URETHRAL SUPPORT SYSTEM