BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA SUPREME SIZE 3

    MDR report key: 19699637 · Received July 9, 2024

    Report

    Report Number
    8040412-2024-00159
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 9, 2024
    Report Date
    June 13, 2024
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE DEVICE WAS RETURNED AND SENT TO THE MANUFACTURING SITE FOR INVESTIGATION. THE MANUFACTURING SITE REPORTS "ONE COMPLAINT RECEIVED FROM CHINA RELATED TO DAMAGE FOUND DURING USE. BASED ON THE COMPLAINT DESCRIPTION AND REVIEW OF DHR FOR THE AFFECTED LOT, NO ABNORMALITIES FOUND." IT WAS ALSO REPORTED THAT "BY REVIEWING SAMPLE (BY NOT OPENING THE SAMPLE), THE DEVICE ARTWORK LABEL ON THE SAMPLE WAS NOT SAME AS PER LOT THAT MANUFACTURE IN 2022. AS PER PAJ-2200-007 REV N LMA SUPREME AIRWAY TUBE PRINT DETAIL ARTWORK, ALL DEVICE THAT MANUFACTURE AFTER SEP 2021, SHALL BE PRINTED AS PER BELOW ARTWORK. THIS POSSIBILITY THAT LOT NUMBER WAS WRONG, OR THE DEVICE WAS NOT MANUFACTURE BY KULIM PLANT." THE COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "9 JUNE 2024, DAMAGE FOUND DURING USE, AIR LEAKAGE BREAKAGE DETECTED. A NEW DEVICE WAS USED AND THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "9 JUNE 2024, DAMAGE FOUND DURING USE, AIR LEAKAGE BREAKAGE DETECTED. A NEW DEVICE WAS USED AND THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286358 LMA SUPREME SIZE 3 LMA SUPREME CAE TELEFLEX MEDICAL 11F22B0091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED| NOT REPORTED