BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVAULTA BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 1406548 · Received June 11, 2009

    Report

    Report Number
    9615742-2009-00050
    Event Type
    Other
    Date Received
    June 11, 2009
    Report Date
    October 4, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS ALLEGED BY THE PT'S ATTORNEY: "FOLLOWING AN ANTERIOR REPAIR AND A POSTERIOR REPAIR PERFORMED IN 2007, THE PT EXPERIENCED MENTAL AND PHYSICAL PAIN AND SUFFERING, PERMANENT INJURY, PHYSICAL DEFORMITY, LOSS OF A BODILY ORGAN SYSTEM AND HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES". AN INQUIRY WAS FORWARDED TO THE PT'S PHYSICIAN WHO RESPONDED THAT ALL INQUIRIES CONCERNING THIS PRODUCT SHOULD BE FORWARDED TO HIS ATTORNEY. THE PT'S ATTORNEY PROVIDED THE PT'S IMPLANT CARD. THE DIAGNOSIS AND TYPE OF TREATMENT FOR THIS SPECIFIC PT IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA ZGH00014

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Female Required Intervention