BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMESH XB

    MDR report key: 5032733 · Received August 21, 2015

    Report

    Report Number
    3005841068-2015-00008
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    April 30, 2015
    Report Date
    August 18, 2015
    Manufacturer
    ASPIDE MEDICAL
    Product Code
    OXJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    FOLLOWING REMOVAL OF PREVIOUSLY PLACED MESH AND RE-REPAIR OF A VENTRAL HERNIA USING SURGIMESH XB E-2226 DURING A ROBOTIC LAPAROSCOPIC, THE PATIENT WAS DIAGNOSED WITH PNEUMOPERITONEUM ON (B)(6) 2015. AT RE-EXPLORATION THE PATIENT WAS FOUND TO HAVE A TRANSVERSE COLON ENTEROTOMY WHICH WAS REPAIRED AND TREATED WITH CIPRO/FLAGYL AND A WOUND VAC. ON POD 3 THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR AN I AND D WITH INTERMEDIATE CLOSURE PERFORMED. ON POD 8 THE PATIENTS WOUND VAC WAS TAKEN DOWN AND THE ABDOMINAL WOUND PACKED WITH AQUACEL AND COVERED WITH GAUZE. ON POD 9 THE PATIENT WAS TRANSFERRED TO THE SAR WHERE HER VITAL SIGNS WERE STABLE. WOUND TREATMENT CONTINUES WITH THE XB E-2226 IN PLACE. STERILITY OF THE XB E-2226 WAS CONFIRMED WITH THE MANUFACTURERS STERILIZATION RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555160 SURGIMESH XB TINTRA E-2226 OXJ ASPIDE MEDICAL TINTRA E-2226 F09288A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention