BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3094007 · Received April 4, 2013

    Report

    Report Number
    9615742-2013-00239
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    June 27, 2013
    Report Date
    March 7, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K012949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SUPPLEMENTAL MDR# 01 SENT TO FDA ON 02/23/2015.

    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.

    Description of Event or Problem · 1

    (INTERIM MEDICAL RECORDS FOR THE TIME PERIOD (B)(6) 2003-(B)(6) 2011 ARE EXTRANEOUS TO COVIDIEN MESH CASE UPON REVIEW) (B)(6) 2011-(B)(6) 2011 - COMPLAINS OF BLADDER INCONTINENCE, HAS NO REAL FEELING AS TO WHEN NEEDS TO GO THE BATHROOM, STATES TOVIAZ HELPED HER WITH BLADDER SYMPTOMS. (MEDICAL RECORDS FURTHER TO (B)(6) 2011 ARE EXTRANEOUS TO COVIDIEN MESH CASE UPON REVIEW)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139689 URETEX SUPPORT PP KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION C23029SUP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other