BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMESH XB

    MDR report key: 5032731 · Received August 21, 2015

    Report

    Report Number
    3005841068-2015-00006
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    May 6, 2015
    Report Date
    August 18, 2015
    Manufacturer
    BG 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

    ON (B)(6) 2015 PATIENT HAD AN OPEN VENTRAL HERNIA REPAIR AND POST OPERATIVELY SHOWED NO BOWEL MOVEMENT WITH TACHYCARDIA AND ABDOMINAL PAIN. A CT SCAN SHOWED A FLUID COLLECTION BEHIND THE ABDOMINAL WALL. THE FLUID COLLECTION WAS DRAINED ON (B)(6) 2015 SHOWING PURULENT MATERIAL AND THE PATIENT WAS STARTED ON ORGANISM SPECIFIC ANTIBIOTICS. THE XB TINTRA E-2226 WAS CONFIRMED STERILE THROUGH REVIEW OF MANUFACTURER STERILIZATION RECORDS. ON (B)(6) 2015 A FOLLOW-UP CT SCAN SHOWED NO FURTHER FLUID COLLECTION BEHIND THE ABDOMINAL WALL. THE PATIENT WAS AMBULATING BY (B)(6) 2015 AND DISCHARGED WITH THEIR DRAIN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555299 SURGIMESH XB TINTRA E-2226 OXJ BG MEDICAL TINTRA E-2226 F009288A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention