BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 5 (150050)

    MDR report key: 9528317 · Received December 28, 2019

    Report

    Report Number
    9681900-2019-00056
    Event Type
    Malfunction
    Date Received
    December 28, 2019
    Date of Event
    October 7, 2019
    Report Date
    December 6, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE CUFF WAS TORN. THE DEVICE WAS UNABLE TO HOLD AIR DUE TO THE TEAR. UPON CLOSER EXAMINATION THERE WERE DENT MARKS/SCRATCH LINES THAT EXTENDED FROM THE FAILURE LOCATION. THE RED PLUG VENT WAS FOUND TO BE FUNCTIONAL. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. THE DEVICE WAS MOST LIKELY PUNCTURED/CUT INADVERTENTLY DUE TO HANDLING BY THE USER.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "CUFF BREAKAGE DETECTED WHEN APPLYING LUBRICATION. RECORD CARD WAS NOT RETURNED FROM THE FACILITY. NO INFORMATION ON HOW MANY TIMES THEY HAVE USED BEFORE THE ALLEGED EVENT. DRIED LUBRICATION ON THE PRODUCT.". NO PATIENT INVOLVEMENT. ISSUE DETECTED PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "CUFF BREAKAGE DETECTED WHEN APPLYING LUBRICATION. RECORD CARD WAS NOT RETURNED FROM THE FACILITY. NO INFORMATION ON HOW MANY TIMES THEY HAVE USED BEFORE THE ALLEGED EVENT. DRIED LUBRICATION ON THE PRODUCT." NO PATIENT INVOLVEMENT. ISSUE DETECTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322991 LMA PROSEAL, REU, SIZE 5 (150050) LMA PROSEAL CAE TELEFLEX MEDICAL MFADSB

    Patients

    Seq Age Sex Outcome Treatment
    1