BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP HALO NEEDLE KIT X1

    MDR report key: 2901082 · Received November 8, 2012

    Report

    Report Number
    9615742-2012-00553
    Event Type
    Injury
    Date Received
    November 8, 2012
    Date of Event
    November 10, 2005
    Report Date
    October 16, 2012
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K041176
    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). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #409236 FOR AN "UNKNOWN SOFRADIM." ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: (B)(6) 2012, URETEX TO URETHRAL SUPPORT SYSTEM,(B)(6). ATTORNEY.

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A REPAIR PROCEDURE AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED SIGNIFICANT PAIN, HAS SUSTAINED PERMANENT INJURY, AND WILL LIKELY UNDERGO CORRECTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP HALO NEEDLE KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention| O