BEUDAMED
    FDA Adverse Event Other Summary report: N

    STANDARD VIA-GUARD

    MDR report key: 1635498 · Received March 11, 2010

    Report

    Report Number
    3023415-2010-00001
    Event Type
    Other
    Date Received
    March 11, 2010
    Date of Event
    February 17, 2008
    Report Date
    March 8, 2010
    Manufacturer
    SURGIMARK, INC.
    Product Code
    JOL
    PMA / PMN Number
    K871950
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS MFG TO BE RADIOLOGICALLY VISIBLE AND MADE OF APPROPRIATE BIOCOMPATIBLE MATERIALS IN CONSIDERATION OF THE RISK OF UNINTENDED RETENTION. THE DEVICE WAS IDENTIFIED RADIOLOGICALLY AND THE PT IS REPORTED TO BE ASYMPTOMATIC IN RESPECT TO THE DEVICE. AT THIS TIME INTERVENTION TO REMOVE THE RETAINED DEVICE HAS NOT BEEN PERFORMED TO OUR KNOWLEDGE. WHEN WE LEARN OF ANY CHANGE WE WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2008, A SURGEON AT (B)(6) HOSPITAL IN (B)(6) PERFORMED AN APPENDECTOMY ON A PT AND LEFT A VIAGUARD SLEEVE IN THE ABDOMEN. THE VIAGUARD SLEEVE WAS IDENTIFIED AS A RETAINED FOREIGN BODY ON A CT SCAN, PERFORMED ON THE SAME PT ON (B)(6) 2010. THE PT'S CONDITION IS REPORTED AS ASYMPTOMATIC WITH RESPECT TO THE FOREIGN BODY, AND TO OUR KNOWLEDGE AT THIS TIME, A COURSE OF ACTION HAS NOT BEEN DETERMINED BY THE SURGEON, PT OR HOSP WITH RESPECT TO MEDICAL OR SURGICAL INTERVENTION. THE FOREGOING INFO WAS COMMUNICATED BY A WRITTEN DOCUMENT RECEIVED FROM (B)(6) HOSP RISK MANAGEMENT DATED (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD VIA-GUARD SAME JOL SURGIMARK, INC. SMP-2006-001SS 1023540

    Patients

    Seq Age Sex Outcome Treatment
    1