BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL REU INTRODUCER (3, 4 & 5)

    MDR report key: 9538083 · Received January 2, 2020

    Report

    Report Number
    9681900-2020-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 10, 2019
    Report Date
    December 10, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "THE RUBBER ON THE END OF THE PROSEAL INTRODUCER HAS BECOME DETACHED FROM THE METAL FRAMEWORK". THE REPORTED ISSUE WAS FOUND IN PREPARATION FOR USE. NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE RUBBER ON THE END OF THE PROSEAL INTRODUCER HAS BECOME DETACHED FROM THE METAL FRAMEWORK". THE REPORTED ISSUE WAS FOUND IN PREPARATION FOR USE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972 LMA PROSEAL REU INTRODUCER (3, 4 & 5) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL UNKNOWN

    Patients

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