BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE PACK OF TOWELS; 8 TOWEL PK (FF)

    MDR report key: 2117399 · Received May 30, 2011

    Report

    Report Number
    2117399
    Event Type
    Malfunction
    Date Received
    May 30, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 30, 2011
    Manufacturer
    SRI SURGICAL
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLES WERE NOTED ON ONE OF THE TOWELS AFTER A STERILE PACK WAS OPENED ONTO THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE PACK OF TOWELS; 8 TOWEL PK (FF) STERILE PACK OF TOWELS; 8 TOWEL PK (FF) KKX SRI SURGICAL NA 11102

    Patients

    Seq Age Sex Outcome Treatment
    1 *