BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMESH

    MDR report key: 5057543 · Received August 17, 2015

    Report

    Report Number
    3005841068-2015-00009
    Event Type
    Injury
    Date Received
    August 17, 2015
    Date of Event
    July 23, 2015
    Report Date
    August 15, 2015
    Manufacturer
    ASPIDE MEDICAL
    Product Code
    OXJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    PATIENT RETURNED TO THE SURGEON AFTER GAINING (B)(6) SINCE PRIOR HERNIA REPAIR ON (B)(6) 2013, W/SIGNS OF BOWEL OBSTRUCTION AND WHAT LOOKED TO BE A LATERAL RECURRENCE. ON (B)(6) 2015, THE PREVIOUSLY PLACED SURGIMESH XB TINTRAL E-2226 WAS REMOVED AND REPLACED W/AN XB TINTRA E-3030 W/OUT CONSEQUENCE. THE XB E-2226 SHOWED NO SIGNS OF FAILURE EXCEPT THAT THE FIXATION TACKS HAD PULLED OUT OF THE ABDOMINAL WALL TISSUE IN PLACES. THE PATIENT RECOVERED UNEVENTFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544018 SURGIMESH OXJ ASPIDE MEDICAL SURGIMESH XB FO6298A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention