BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIZUHO OSI SPINAL SURGICAL TABLE

    MDR report key: 2680315 · Received June 1, 2012

    Report

    Report Number
    2921578-2012-00010
    Event Type
    Other
    Date Received
    June 1, 2012
    Report Date
    May 28, 2012
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE HAD MULTIPLE ATTEMPTS TO CONTACT HOSPITAL TO ACQUIRE INFO RELATING TO THE INCIDENT. EACH ATTEMPT FAILED, WE FINALLY WERE ABLE TO ACQUIRE INPUT FROM DR. (B)(6) AT THE (B)(6) HOSPITAL AND STATED THAT THEY WERE NOW USING LOBAN AND/OR DRAPES AND THERE IS NO LONGER A PROBLEM. AS WE RECOMMEND TO OUR CUSTOMERS TO USE THE SHEARGUARD COVERS/DRAPES TO REDUCE SHEARING, THE CUSTOMER IS NOW USING THE COVERS AND/OR LOBAN. LOBAN IS AN ANTIMICROBIAL SURGICAL INCISE DRAPE WITH AN IODOPHOR IMPREGNATED ADHESIVE, DESIGNED TO PROVIDE A STERILE SURFACE ON THE PT. SINCE THE HOSPITAL IS COVERING THE PADS AS WE HAVE RECOMMENDED, AND NO LONGER HAVING ISSUES, WE ARE CLOSING THIS COMPLAINT.

    Description of Event or Problem · 1

    DURING USE OF THE MIZUHO OSI SPINAL FRAME TABLE, THE PT WAS PLACED DIRECTLY ON THE TABLE AND CHEST PAD WITH NO SHEARGUARD COVER. THE PT HAD A BLISTER ON THE CHEST. THE HEALTHCARE WORKERS USED COVERING (LOBAN OR DRAPES) ON THE PADS AND DID NOT HAVE THIS PROBLEM CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIZUHO OSI SPINAL SURGICAL TABLE OPERATING ROOM TABLE JEA MIZUHO OSI 5943

    Patients

    Seq Age Sex Outcome Treatment
    1 Other