BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 6149502 · Received December 6, 2016

    Report

    Report Number
    2936999-2016-01027
    Event Type
    Injury
    Date Received
    December 6, 2016
    Report Date
    November 16, 2016
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DID NOT RETAIN THE MODEL AND LOT NUMBER WHICH DETERMINES THE DATE OF MANUFACTURE AND THE 510K. PATIENT INFORMATION ID AS WELL AS ADDITIONAL INFORMATION ASSOCIATED WITH THE COMPLAINT HAVE BEEN REQUESTED AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE HOLES OF THE TRACHEOSTOMY TUBE ARE BREAKING. RECANNULATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798268 SHILEY UNSPECIFIED TRACHEAL TUBE BTR COVIDIEN UNKTRACH

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention