BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX SILICONISED PROF CUFF TRACHEOSTOMY ADJ FLANGE

    MDR report key: 8426337 · Received March 16, 2019

    Report

    Report Number
    3012307300-2019-01347
    Event Type
    Injury
    Date Received
    March 16, 2019
    Date of Event
    February 1, 2019
    Report Date
    March 15, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: FOREIGN (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX SILICONISED PROF CUFF TRACHEOSTOMY ADJ FLANGE LEAKED AT THE CUFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219607 PORTEX SILICONISED PROF CUFF TRACHEOSTOMY ADJ FLANGE TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH JOH SMITHS MEDICAL ASD, INC. 100/523/070

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention