BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIWRAP

    MDR report key: 570690 · Received February 1, 2005

    Report

    Report Number
    2031733-2005-00001
    Event Type
    Injury
    Date Received
    February 1, 2005
    Report Date
    January 4, 2005
    Manufacturer
    MACROPORE BIOSURGERY, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS DIAGNOSED WITH SBO AND REQUIRED LYSIS OF ADHESION. THEY HAD PREVIOUS ABDOMINAL SURGICAL PROCEDURES. SURGERY WAS LOOP ILEOSTOMY AND ADHYSIOLYSIS. TWO STAGE PROCEDURE. 6 WEEKS POST OP PT HAD ABSCESS IN LOWER PART OF WOUND SITE. WOUND WAS DRAINED. AT SECOND STAGED PROCEDURE IT WAS OBSERVED THAT SURGWRAP WAS IN THE WOUND / INCISION AREA ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIWRAP SURGICAL MESH FTL MACROPORE BIOSURGERY, INC. NA UI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention