BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PRLSEAL, REU, SIZE 4

    MDR report key: 3966548 · Received June 26, 2014

    Report

    Report Number
    9681900-2014-00031
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    TELEFLEX ASIA PTE LTD
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THE DEVICE WAS OBSERVED TO HAVE A TORN CUFF. THE REPORTED DEFECT WAS DETECTED AFTER THE COMPLETION OF A PROCEDURE. THERE WAS NO REPORTED HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373901 LMA PRLSEAL, REU, SIZE 4 LARYNGEAL MASK AIRWAY BTR TELEFLEX ASIA PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1