BEUDAMED
    FDA Adverse Event Other Summary report: N

    PELVITEX POLYPROPYLENE MESH

    MDR report key: 6294204 · Received February 1, 2017

    Report

    Report Number
    1018233-2012-01616
    Event Type
    Other
    Date Received
    February 1, 2017
    Report Date
    January 12, 2017
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    COMPLAINT #(B)(4). PER ADDITIONAL INFORMATION RECEIVED. THE PATIENT HAS EXPERIENCED URINARY TRACT, VAGINAL AND BLADDER INFECTIONS, CHRONIC AND RECURRENT ALSO, CONTINUED URINARY INCONTINENCE, ADHESIONS, RECURRENT VAGINAL PAIN, UTERINE PROLAPSE, WOUND HEALING PROBLEMS, (B)(6) 2012 EXPLORATORY SURGERY DUE TO BLADDER INFECTIONS, AND DECREASED ACTIVITIES.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLADDER LESION, WHITISH AREA INSIDE THE BLADDER NECK, CYSTITIS CYSTICA (INFLAMMATION), AND REQUIRED ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78274 PELVITEX POLYPROPYLENE MESH Mesh, surgical, polymeric FTL SOFRADIM PRODUCTION NA PJC00435

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention ALIGN URETHRAL SUPPORT SYSTEM