BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUSTOM SPINAL ANESTHESIA TRAYDOUBLE DECK

    MDR report key: 366575 · Received December 17, 2001

    Report

    Report Number
    6000001-2001-00563
    Event Type
    Death
    Date Received
    December 17, 2001
    Date of Event
    November 19, 2001
    Report Date
    November 19, 2001
    Manufacturer
    CLEVELAND
    Product Code
    CAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A TOTAL KNEE REPLACEMENT, WAS DISCHARGED HOME, AND EXPIRED. AN AUTOPSY REVEALED NO SPECIFIC CAUSE OF DEATH. ALL PRODUCTS AND MEDICATIONS ARE BEING SCRUTINIZED BY THE CDC FOR A POSSIBLE CAUSE. THERE IS NO INFO LINKING THE EVENT TO THIS SPINAL TRAY OR THE MEDICATIONS IT CONTAINS. DECEMBER ANECDOTAL REPORT DURING ORIGINAL CONVERSATION OF TWO OTHER DEATHS IN THIS STATE. THE ONLY COMMONALITY WAS THE TYPE OF SURGERY - KNEE REPLACEMENT. NO USE OF THIS DEVICE IN THE OTHER INSTANCES. CALLS TO RN RISK MGR - LEFT VOICE MAIL FOR FURTHER DETAILS. CALLS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57131 CUSTOM SPINAL ANESTHESIA TRAYDOUBLE DECK SPINAL ANESTHESIA TRAY CAZ CLEVELAND NA GD745323

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death