BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 3 (150030)

    MDR report key: 3647329 · Received January 6, 2014

    Report

    Report Number
    9681900-2014-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 4, 2013
    Report Date
    December 16, 2013
    Manufacturer
    TELEFLEX MEDICAL ASIA PTE LTS
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THERE WAS A TEAR IN THE CUFF OF THE DEVICE THAT WAS DISCOVERED BY THE ANESTHETIST PRIOR TO USE ON A PATIENT. THE CUSTOMER USED A DIFFERENT LMA DEVICE SUCCESSFULLY AND THE DEFECTIVE DEVICE WAS NOT USED. NO REPORT OF A PATIENT INJURY OR A DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7105 LMA PROSEAL, REU, SIZE 3 (150030) LARYNGEAL MASK AIRWAY CAE TELEFLEX MEDICAL ASIA PTE LTS HFAAVG

    Patients

    Seq Age Sex Outcome Treatment
    1