BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMESH WN

    MDR report key: 5070411 · Received September 9, 2015

    Report

    Report Number
    3005841068-2015-00011
    Event Type
    Injury
    Date Received
    September 9, 2015
    Date of Event
    August 10, 2015
    Report Date
    September 3, 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

    ON (B)(6) 2014 THE PATIENT HAD AN OPEN VENTRAL HERNIA REPAIR USING TWO PIECES OF SURGIMESH WN T1415-8. APPROXIMATELY A MONTH P.O. THE PATIENTS SKIN WOUND FROM THE VENTRAL HERNIA REPAIR BROKE DOWN. ON (B)(6) 2014 THE PATIENTS WOUND WAS IRRIGATED, DEBRIDED AND RE-CLOSED. THE PATIENT WAS GIVEN ANTIBIOTICS ON (B)(6) 2014 THE PATIENTS WOUND WAS AGAIN IRRIGATED, DEBRIDED AND A WOUND VAC PLACED. ON (B)(6) 2015 THE PATIENTS ABDOMINAL WOUND WAS MAKING PROGRESS AND THERE WAS EVIDENCE OF GRANULATION TAKING PLACE. AT A (B)(6) 2015 CHECK-UP THE PATIENTS ABDOMINAL WOUND WAS CONTINUING TO HEAL, A BIT SLOWLY. ON (B)(6) 2015 THE PATIENT WAS BROUGHT TO THE SURGEONS OFFICE FOR EXCISION OF UNINCORPORATED T1415-8, IRRIGATION OF THE SITE AND DEBRIDEMENTS. BY (B)(6) 2015 THE PATIENT CALLED INDICATING THAT DRAINAGE HAD INCREASED. ON (B)(6) 2015 THE SURGEON EXCISED THE REMAINING T1415-8 AND CLOSED THE PATIENTS ABDOMINAL WALL. THE STERILITY AND ACCEPTABILITY FOR CLINICAL USE OF THE SURGIMESH WN T1415-8 WAS CONFIRMED THROUGH THE MANUFACTURER LOT HISTORY RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596543 SURGIMESH WN T1415-8 OXJ ASPIDE MEDICAL T1415-8 F08899A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention