BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN URETEX MESH PRODUCT

    MDR report key: 3833418 · Received May 19, 2014

    Report

    Report Number
    9615742-2014-00168
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    May 19, 2014
    Report Date
    April 30, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY. SHE EXPERIENCES MESH EXPOSURE, INFECTION, PAIN, URINARY PROBLEMS, INCONTINENCE, MESH EROSION, VAGINAL SCARRING, OCCASIONAL PAIN DURING INTERCOURSE, AND SHE NEEDS CORRECTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295774 UNKNOWN URETEX MESH PRODUCT NONE OTN SOFRADIM PRODUCTION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other