BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 5873537 · Received August 12, 2016

    Report

    Report Number
    9611109-2016-00562
    Event Type
    Death
    Date Received
    August 12, 2016
    Report Date
    August 8, 2016
    Manufacturer
    UNKNOWN
    Product Code
    OEZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT WERE NOT PROVIDED. THE DATE OF DEATH WAS NOT PROVIDED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. AN EVENT DATE WAS NOT PROVIDED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. NO DEVICE INFORMATION WAS PROVIDED IN THE LEGAL COMPLAINT. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. AS NO DEVICE INFORMATION WAS PROVIDED IN THE LEGAL COMPLAINT, IT IS UNKNOWN WHAT TYPE OF DEVICE IS UNDER COMPLAINT. THE PRODUCT CODE SELECTED (OEZ) IS NOT CONFIRMED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. AS DEVICE INFORMATION WAS NOT PROVIDED, THE CORRECT MANUFACTURER COULD NOT BE IDENTIFIED. THE COUNTRY SELECTION ((B)(6)) IS NOT CONFIRMED. THE MODEL AND SERIAL NUMBER HAVE NOT BEEN PROVIDED AND THE UDI COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. AS DEVICE INFORMATION WAS NOT PROVIDED, THE CORRECT MANUFACTURER COULD NOT BE IDENTIFIED. THE COUNTRY SELECTION ((B)(6)) IS NOT CONFIRMED. A MODEL NUMBER WAS NOT PROVIDED, SO THE 510(K) NUMBER COULD NOT BE DETERMINED. THE SERIAL NUMBER WAS NOT PROVIDED, SO IT IS UNKNOWN IF THE UNIT HAS ALREADY BEEN RETURNED OR NOT. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. THE SERIAL NUMBER WAS NOT PROVIDED, SO THE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. SORIN GROUP (B)(4) MANUFACTURES THE SORIN HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). ON AUGUST 8, 2016, SORIN GROUP (B)(4) WAS NOTIFIED OF A LEGAL COMPLAINT THAT WAS FILED ON (B)(6) 2016. THE COMPLAINT IDENTIFIED A SINGLE PATIENT FROM (B)(6) HOSPITAL. THE PATIENT HAS EXPIRED, BUT IT IS NOT KNOWN WHEN THE DEATH OCCURRED. AS NO ADDITIONAL INFORMATION REGARDING THE PATIENT OR THE REASON FOR THE COMPLAINT WAS PROVIDED, THE REPORT COULD NOT BE CONNECTED TO A PREVIOUS COMPLAINT RECEIVED FROM THE FACILITY. THE INVESTIGATION IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON RECEIPT OF ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ON AUGUST 8, 2016, SORIN GROUP (B)(4) WAS NOTIFIED OF A LEGAL COMPLAINT THAT WAS FILED ON (B)(6) 2016. THE COMPLAINT IDENTIFIED A SINGLE PATIENT FROM (B)(6) HOSPITAL. THE PATIENT HAS EXPIRED, BUT IT IS NOT KNOWN WHEN THE DEATH OCCURRED. AS NO ADDITIONAL INFORMATION REGARDING THE PATIENT OR THE REASON FOR THE COMPLAINT WAS PROVIDED, THE REPORT COULD NOT BE CONNECTED TO A PREVIOUS COMPLAINT RECEIVED FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523671 UNKNOWN UNKNOWN OEZ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death