BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 2841275 · Received October 25, 2012

    Report

    Report Number
    9615742-2012-00490
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    August 23, 2006
    Report Date
    September 25, 2012
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE INFO: AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM, CATALOG # 486020, (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. ADDITIONAL INFORMATION FROM IMPORTER REPORT: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR SYSTEM FTL SOFRADIM PRODUCTION NA ZGB00240

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| MID-URETHRAL SLING SYSTEM| BOSTON SCIENTIFIC OBTRYX TRANSOBTURATOR| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM