BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALSHIELD ZIPPERED SURGICAL TOGA, LARGE

    MDR report key: 4340523 · Received December 15, 2014

    Report

    Report Number
    1526350-2014-00480
    Event Type
    Malfunction
    Date Received
    December 15, 2014
    Date of Event
    November 24, 2014
    Report Date
    November 24, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE HOSP AND WILL NOT BE RETURNED TO THE MFR FOR EVAL. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FLUID STRIKE THROUGH NOTICED ON THE FOREARM AFTER REMOVING THE GOWN AT THE END OF THE PROCEDURE. IT WAS ALSO STATED TAT CUFFS ON THE SURGICAL GLOVES DID NOT ROLL UP AND THE SLEEVE CUFF WAS INTACT. ADD'L CLINICAL FOLLOW UP DETERMINED THAT THE SCRUB TECH INVOLVED IN THIS REPORT DID NOT REQUIRE ANY MEDICAL ATTENTION AND THERE WAS NO EXPOSURE TO OPEN SKIN OR MUCOUS MEMBRANES. ADD'L FOLLOW UP DETERMINED THAT THE LOT NUMBER OF THE DEVICE WAS UNABLE TO BE CONFIRMED BECAUSE THE PRODUCT PACKAGING WAS ALREADY DISCARDED WHEN THE EVENT OCCURRED; HOWEVER THE DEVICE MAY HAVE BEEN FROM EITHER LOT #D140493 OR LOT #D140503. THE DEVICE WAS DISCARDED BY THE HOSP FOLLOWING THE SURGICAL PROCEDURE. NO ADD'L CLINICAL INFO WAS RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820559 TOTALSHIELD ZIPPERED SURGICAL TOGA, LARGE TOTALSHIELD ZIPPERED SURGICAL TOGA, LARGE FYA ZIMMER SURGICAL NA D140503

    Patients

    Seq Age Sex Outcome Treatment
    1