BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRTX MONO POLY LITE MSH 20X20C

    MDR report key: 2823509 · Received October 8, 2012

    Report

    Report Number
    9615742-2012-00520
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: SURGEON COMPLAINED OF MESH SHREDDING AND FALLING APART WHEN SEWING IN PT. THERE WAS NO TISSUE DAMAGE, UNANTICIPATED BLOOD LOSS, UNANTICIPATED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION, CONVERSION TO OPEN PROCEDURE, OR EXTENDED OPERATING ROOM TIME. NO DELAY OVER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRTX MONO POLY LITE MSH 20X20C SOFRADIM MESH FTL SOFRADIM PRODUCTION SLD00501

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR