BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA CLASSIC, REU, SIZE 4 (100040)

    MDR report key: 13738996 · Received March 11, 2022

    Report

    Report Number
    9681900-2022-00012
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Date of Event
    February 18, 2022
    Report Date
    February 18, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    UDI-DI
    14026704611437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED A PHOTO FOR EVALUATION. THE MANUFACTURING SITE HAS REVIEWED THE PHOTO AND CONFIRMED THAT THE CUFF WAS DEFORMED. ALTHOUGH THE COMPLAINT WAS CONFIRMED, A ROOT CAUSE COULD NOT BE DETERMINED WITHOUT THE ACTUAL SAMPLE TO EVALUATE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED "SLIGHT HERNIATION OF THE CUFF, THE PHYSICIAN REPORTED SHE DID NOT FEEL IT SEALED THAT WELL". NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED "SLIGHT HERNIATION OF THE CUFF, THE PHYSICIAN REPORTED SHE DID NOT FEEL IT SEALED THAT WELL". NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884902 LMA CLASSIC, REU, SIZE 4 (100040) LMA CLASSIC CAE TELEFLEX MEDICAL IPN900275 UNKOWN 14026704611437

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown