BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFRADIM PRODUCT

    MDR report key: 2823505 · Received October 8, 2012

    Report

    Report Number
    1219930-2012-00829
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    May 31, 2012
    Report Date
    September 12, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SMALL BOWEL. ACCORDING TO THE REPORTER: PATIENT STATED EXPERIENCING PAIN AFTER MESH WAS PUT IN PLACE. MESH HAD ADHERED TO HER SMALL BOWEL CAUSING INJURY TO IT. PART OF THE MESH WAS TAKEN OUT AND SHE WOULD LIKE FOR THE WHOLE MESH TAKEN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFRADIM PRODUCT SOFRADIM PRODUCT FTL COVIDIEN, FORMERLY US SUR

    Patients

    Seq Age Sex Outcome Treatment
    1