BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 3202334 · Received June 12, 2013

    Report

    Report Number
    9615742-2013-00565
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    February 19, 2007
    Report Date
    May 22, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTP
    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). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER). BARD'S TRACKING NUMBER: (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED INJURY, PAIN, SUFFERING, DISABILITY AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. IT WAS REPORTED THAT LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM (PRODUCT # (B)(4), LOT # OML7010313) WAS USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266075 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSETM OTP SOFRADIM PRODUCTION ZGJ00030

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM: | PRODUCT # UGYKP, LOT # ZGI00806| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM:| PRODUCT # UGYKP, LOT # ZGI00806