BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 2901240 · Received December 10, 2012

    Report

    Report Number
    9615742-2012-00631
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 12, 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).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFO HAS BEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR #1018233-2012-01935, 1018233-2012-01933, 1018233-2012-01934.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R SLING LYNX| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM