BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 3040260 · Received March 18, 2013

    Report

    Report Number
    9615742-2013-00201
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    March 30, 2006
    Report Date
    June 5, 2018
    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 ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM. CATALOG # 486010, LOT# ZFL00173, EXPIRATION DATE: 12/31/2012. (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. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00907.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112294 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR SYSTEM FTL SOFRADIM PRODUCTION NA ZFH00159

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| O AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| GYNECARE TVT| GYNECARE TVT.| UGYKA, PARIETEX UGYTEX PP ANTERIOR KIT X1: LOT ZFL00173, EXP: 12/31/2010, MFR DATE: 12/2005. | GYNECARE TVT| PARIETEX UGYTEX PP ANTERIOR KIT X1: LOT ZFL00173| UGYKA| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM