BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMESH WN

    MDR report key: 4606239 · Received March 7, 2015

    Report

    Report Number
    3005841068-2015-00003
    Event Type
    Injury
    Date Received
    March 7, 2015
    Date of Event
    February 12, 2015
    Report Date
    March 6, 2015
    Manufacturer
    ASPIDE MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K061445
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SOMETIME IN (B)(6) 2014 A WN T1015 WAS IMPLANTED INTO THE PATIENT FOR THE REPAIR OF AN INGUINAL HERNIA USING AN OPEN LICHTENSTEIN TECHNIQUE. AT 7 DAYS FOLLOW-UP, THE PATIENT WAS RECOVERING UNEVENTFULLY. IN (B)(6), THE PATIENT RETURNED TO THE SURGEON WITH WHAT LOOKED LIKE AN INFECTED INGUINAL HERNIA REPAIR. UPON EXPLORATION, THE SURGEON FOUND THE WN T1015 WITH OBVIOUS CELLULITIS. THE WN T1015 WAS REMOVED, CULTURED AND DEMONSTRATED (B)(6). THE PATIENT WAS CLEANED UP AND A NEW PIECE OF WN T1015 IMPLANTED. THE PATIENT WAS RECOVERING UNEVENTFULLY AS OF (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160021 SURGIMESH WN T1015 FTL ASPIDE MEDICAL T1015 F07081A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention