BEUDAMED
    FDA Adverse Event Summary report: N

    SHELHIGH INC PATCH

    MDR report key: 2971524 · Received April 27, 2007

    Report

    Report Number
    2971524
    Date Received
    April 27, 2007
    Report Date
    April 27, 2007
    Product Code
    DXZ
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE HAD RECEIVED A SHELHIGH ON (B)(6) 2007. PT PRESENTED TO (B)(6) EMERGENCY ROOM ON (B)(6) 2007 WITH SWELLING AND TENDERNESS SURROUNDING INCISION R CEA SITE. PT ALSO COMPLAINED OF HOARSENESS OF VOICE AND HAVING DIFFICULTY SWALLOWING. PT RETURNED TO OPERATING ROOM FOR INCISION AND DRAINAGE OF SURGICAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHELHIGH INC PATCH PATCH 1X7 DXZ NR-555-CRT17 060613-NR

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other