BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 1750495 · Received June 14, 2010

    Report

    Report Number
    2936999-2010-00907
    Event Type
    Injury
    Date Received
    June 14, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 21, 2010
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. NO ANALYSIS OR CONCLUSION CAN BE MADE WITHOUT THE DEVICE.

    Description of Event or Problem · 1

    RECEIVED VIA EMAIL (B)(4) MAUDE EVENT REPORT (B)(4): EVENT DATE: (B)(6) 2010. REPORT DATE: (B)(4)2010. EVENT REPORT TYPE: MALFUNCTION; PROBLEM: Y; REPORTER OCCUPATION: OTHER HEALTH CARE PROFESSIONAL; DEVICE OPERATOR: HEALTH PROFESSIONAL; PRODUCT CODE: TUBE TRACHEOSTOMY AND TUBE CUFF (JOH); EVENT DESCRIPTION: VOLUN (B)(4) 2010: OUTERCANNULA FROM TRACHEOSTOMY TUBE WAS CRACKED AT THE HIGHER PART OF THE CANNULA-WHERE THE INNER CANNULA IS LOCKED- PT HAD HER TRACHEOSTOMY TUBE DONE THE DAY BEFORE. NO USER FACILITY REPORT NUMBER PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN/ FORMERLY TYCO HEALTHCARE 0905000868

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention