BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON SHER-I-SLIP STYLET

    MDR report key: 1057126 · Received June 4, 2008

    Report

    Report Number
    3003898360-2008-00039
    Event Type
    Death
    Date Received
    June 4, 2008
    Report Date
    June 3, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BSR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RELEASED BY INSTITUTION FOR MANUFACTURER TO EVALUATE. TELEFLEX MEDICAL IS ATTEMPTING TO GET A LOT NUMBER AND/OR PICTURES OF PRODUCT TO EVALUATE.

    Description of Event or Problem · 1

    EVENT REPORTED TO DISTRIBUTOR AS: A PT HAD BEEN INTUBATED AND WHEN THEY WENT TO REMOVE THE STYLET, PART OF IT REMAINED IN THE PATIENT'S ET TUBE. THE DOCTORS DID NOT NOTICE THAT THIS PIECE WAS STILL IN THE PATIENT AS THE O2 SATURATION LEVELS WERE OK. IT WAS THEN REPORTED THAT THE PATIENT DIED. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON SHER-I-SLIP STYLET STYLET BSR TELEFLEX MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death