BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTEC SPG 4X8 NON ST 10S 16PLY

    MDR report key: 879180 · Received September 15, 2006

    Report

    Report Number
    1018120-2006-00009
    Event Type
    Malfunction
    Date Received
    September 15, 2006
    Date of Event
    August 23, 2006
    Report Date
    August 28, 2006
    Manufacturer
    TYCO HEALTHCARE/ KENDALL
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, A SAMPLE HAS NOT BEEN RECEIVED. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON 08/28/2006, THAT A CUSTOMER HAD A PROBLEM WITH A VISTEC SPONGE THAT WAS INSIDE A SRI SURGICAL KIT. THE CUSTOMER STATES THAT THE 4X8 GAUZE IS CRUMBLING, WHEN USED IN SURGICAL PROCEDURES. ACCORDING TO THE DISTRIBUTOR (SRI SURGICAL), THE INCIDENT OCCURRED DURING OPEN HEART SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTEC SPG 4X8 NON ST 10S 16PLY X-RAY DETECTABLE SPONGE FRO TYCO HEALTHCARE/ KENDALL 7463 61092263

    Patients

    Seq Age Sex Outcome Treatment
    1 YR