BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETEX SUPPORT PP HALO NEEDLE KIT X1

    MDR report key: 3220951 · Received July 3, 2013

    Report

    Report Number
    9615742-2013-00722
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    October 20, 2006
    Report Date
    June 10, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K041176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: STRESS UI / PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304179 RETEX SUPPORT PP HALO NEEDLE KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION SFL00017

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other