BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 5840972 · Received August 2, 2016

    Report

    Report Number
    1018233-2012-01970
    Event Type
    Other
    Date Received
    August 2, 2016
    Report Date
    July 25, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED INFECTION, PAIN, "INABILITY TO LIFT ANYTHING HEAVIER THAN A GALLON OF MILK," AND HELICOBACTER PYLON, ADDITIONAL GENERAL SURGERY TO LOCATE THE SOURCE OF THE INFECTION, AND REMOVAL OF THE MESH IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494429 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM Mesh, surgical, polymeric FTL SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM.| AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM.| PELVIC TO BIOURETHRAL SUPPORT SYSTEM W/ HOOK NEEDLE.