BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND

    MDR report key: 4364123 · Received December 22, 2014

    Report

    Report Number
    3004170064-2014-00284
    Event Type
    Injury
    Date Received
    December 22, 2014
    Report Date
    December 22, 2014
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    083898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED AND EVERYTHING WAS IN ORDER.

    Description of Event or Problem · 1

    THE PT HAD A SCHEDULED OPERATION FOR VENTRAL HERNIA REPAIR. THE DEVICE WAS IMPLANTED ON (B)(6) 2014, IT WAS DISCOVERED THAT THERE WAS WOUND DEHISCENCE, SUTURE PULL OUT AND MESH TEARING. THE SURGEON INDICATED THE PT HAD A CURRENT CHRONIC INFECTION AND A PREVIOUS HISTORY OF NECROTIZING FASCITIS. IT IS NOT KNOWN IF THE DEVICE HAS BEEN EXPLANTED. IT IS NOT KNOWN WHAT THE PT'S CURRENT CONDITION IS. IT IS POSSIBLE THAT THE PT'S CONDITION (CONTAMINATION/INFECTION) CONTRIBUTED/CAUSED THE DEVICE TO FAIL. THE DEVICE INSTRUCTIONS FOR USE CAUTION AGAINST USE OF THE DEVICE IN AN INFECTED SURGICAL LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841624 SURGIMEND SURGICAL MESH FTM TEI BIOSCIENCES INC. 606-300-017 1309051

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| O