BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSCT SCT SPECIALIZED

    MDR report key: 6502491 · Received April 18, 2017

    Report

    Report Number
    2936999-2017-05133
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Date of Event
    March 16, 2017
    Report Date
    March 22, 2017
    Manufacturer
    MMJ SA DE CV (USD)
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION (ID, AGE, SEX, WEIGHT) 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

    MEDTRONIC RECEIVED A REPORT THE TRACHEOSTOMY TUBE EXPERIENCED CUFF INFLATION/DEFLATION ISSUE. CUSTOMER ADVISED THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283733 MSCT SCT SPECIALIZED JOH MMJ SA DE CV (USD) MSCT 16L0203JZX

    Patients

    Seq Age Sex Outcome Treatment
    1