BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMESH

    MDR report key: 3780982 · Received April 18, 2014

    Report

    Report Number
    3005841068-2014-00004
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ASPIDE MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K061445
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME TO HOSPITAL FOR AN EMERGENT COLORECTAL SURGICAL PROCEDURE ON (B)(6) 2013. FOLLOWING THE COLORECTAL REPAIR A WN T221510-8 WAS IMPLANTED IN THE RETRORECTUS POSITION TO REPAIR AN EXISTING HERNIA. THE DOCTOR KNEW THAT THE WN WAS BEING IMPLANTED IN A CONTAMINATED FIELD BUT HE HAD NO OTHER CHOICE AS THE HOSPITAL DID NOT HAVE ANY OTHER MESH (ABSORBABLE OR BIOLOGIC) TO USE AND HE DID NOT WANT TO SENT THE PATIENT HOME WITH A HERNIA. ON (B)(6) 2014 DR. ERCANBRACK REMOVED THE WN T221510-8 WHICH HAD BECOME INFECTED AND CLOSED THE DEFECT PRIMARILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238959 SURGIMESH SURGIMESH WN FTL ASPIDE MEDICAL T221510-8 F04824A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention