BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 3001090 · Received March 5, 2013

    Report

    Report Number
    9615742-2013-00150
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    September 30, 2011
    Report Date
    December 12, 2017
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): BRAND NAME: AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM, (B)(6).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93996 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR SYSTEM FTL SOFRADIM PRODUCTION NA ZGJ00365

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention| O UNK.