BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACKSON TABLE KIT

    MDR report key: 4849976 · Received June 16, 2015

    Report

    Report Number
    1034876-2015-00001
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    May 11, 2015
    Report Date
    June 12, 2015
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    CCX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO DISCREPANCIES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS OBTAINED FROM THE SALES REPRESENTATIVE ON (B)(6) 2015. IT WAS IDENTIFIED THE ISSUE IS WITH THE BOUFFANT COVERS AND NOT THE FOAM PADDING. AN ADDITIONAL FOLLOW-UP WAS PERFORMED ON (B)(6) 2015. THE REPORTING CUSTOMER HAS A COMPARISON DEVICE THAT CONTAINS PADDING. IN ADDITION, THE SALES REPRESENTATIVE IS ATTEMPTING TO VIEW THE TABLE ON WHICH THE INCIDENT OCCURRED. A FOLLOW-UP WITH THE SALES REPRESENTATIVE WAS PERFORMED ON (B)(6) 2015. NO PICTURES HAVE BEEN PROVIDED OF THE TABLE. IF OR WHEN THE INFORMATION IS RECEIVED, THE COMPLAINT WILL BE REOPENED FOR UPDATES. THE QFI REPORT WAS REVIEWED FOR SALES AND SIMILAR COMPLAINT INFORMATION. DEROYAL HAS SOLD (B)(4) CASES OF THE FINISHED GOOD FROM 2013 TO PRESENT. NO PREVIOUS REPORTS OF THIS NATURE FOR THE FINISHED GOOD WERE IDENTIFIED. CORRECTION: A CORRECTION HAS NOT BEEN TAKEN. ROOT CAUSE ANALYSIS: THE REPORTED ISSUE HAS BEEN DETERMINED TO BE AN ISOLATED REPORT DUE TO AN UNDETERMINED ROOT CAUSE. THE COMPONENTS IDENTIFIED BY THE COMPLAINT WERE IDENTIFIED AS COVERS. MORE INFORMATION IS NEEDED TO DETERMINE A ROOT CAUSE AS THE CONDITION OF THE TABLE AND SIZE OF THE PATIENT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. PREVENTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A PREVENTIVE ACTION HAS NOT BEEN TAKEN.

    Description of Event or Problem · 1

    CLIENT COMPLAINS ABOUT THE HIP AND THIGH PADS CAUSING ABRASIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390318 JACKSON TABLE KIT SURGICAL TABLE CUSHION CCX DEROYAL INDUSTRIES, INC. 36733329

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention