BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMESH XB

    MDR report key: 5070407 · Received September 9, 2015

    Report

    Report Number
    3005841068-2015-00010
    Event Type
    Injury
    Date Received
    September 9, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 31, 2015
    Manufacturer
    ASPIDE MEDICAL
    Product Code
    OXJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NM, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD AN OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2015 WITH SURGIMESH XB TINTRA E-1522. THE ABDOMINAL WALL INCISION NEVER HEALED AND OPENED UP. ON (B)(6) 2015 ANOTHER DOCTOR AT THE (B)(6) MEDICAL CENTER DID AN OPEN EXPLORATORY LAPAROPTOMY TO DEBRIED AND IRRIGATE THE WOUND IN AN ATTEMPT TO CLEAR UP THE INFECTION. ON (B)(6) 2015 A SECOND AND THIRD OPEN EXPLORATORY LAPAROTOMY WAS PERFORMED TO IRRIGATE AND DEBRIED THE WOUND. DURING THE FINAL IRRIGATION AND DEBRIEDMENT THE TINTRA E-1522 WAS REMOVED. PER HOSPITAL POLICY THE TINTRA E-1522 WAS KEPT AT THE HOSPITAL AND FINALLY DISPOSED OF. THE STERILITY AND ACCEPTABILITY FOR CLINICAL USE OF THE SURGIMESH XB TINTRA E-1522 WAS CONFIRMED THROUGH THE MANUFACTURER LOT HISTORY RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596545 SURGIMESH XB TINTRA E-1522 OXJ ASPIDE MEDICAL TINTRA E-1522 F08761A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention