BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA UNIQUE SIZE 4

    MDR report key: 10289398 · Received July 17, 2020

    Report

    Report Number
    9681900-2020-00008
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    June 18, 2020
    Report Date
    June 30, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE DEVICE SEPARATED WHEN IT WAS PULLED OUT OF THE PATIENT. IT WAS REPORTED THE OVAL (TEAR SHAPED) PART AT THE END DISCONNECTED FROM THE TUBE AND WAS RETRIEVED BY THE PHYSICIAN USING A CLAMP. NO PATIENT INJURY OCCURRED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE SEPARATED WHEN IT WAS PULLED OUT OF THE PATIENT. IT WAS REPORTED THE OVAL (TEAR SHAPED) PART AT THE END DISCONNECTED FROM THE TUBE AND WAS RETRIEVED BY THE PHYSICIAN USING A CLAMP. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753788 LMA UNIQUE SIZE 4 LMA UNIQUE CAE TELEFLEX MEDICAL PMCKHA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.