BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 1930229 · Received December 1, 2010

    Report

    Report Number
    2936999-2010-01347
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    February 19, 2010
    Report Date
    November 3, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. NO ANALYSIS OR CONCLUSIONS CAN BE MEADE WITHOUT THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    A COPY OF MAUDE REPORT WITH AWARE DATE OF (B)(6) 2010 WAS RECEIVED. THE REPORTED STATED: MODEL LPC; EVENT DATE: (B)(6) 2010; EVENT TYPE: OTHER; PT OUTCOME; OTHER. DESCRIPTION: TRACHEOSTOMY TUBE WAS INSERTED IN PT ON (B)(6) 2010 AND HAD TO BE REPLACED BECAUSE, THE CUFF WOULD NOT HOLD AIR. DATES OF USE: 2010 - 2010. DIAGNOSIS OR REASON FOR USE: VENTILATOR SUPPORT AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 0902001779

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention