BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 6119473 · Received November 21, 2016

    Report

    Report Number
    2936999-2016-00963
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 25, 2016
    Manufacturer
    FOREFRONT MEDICAL TECHNOLOGY
    Product Code
    CAE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION (ID, AGE, SEX, WEIGHT) AS WELL AS ADDITIONAL INFORMATION ASSOCIATED WITH THE COMPLAINT HAVE BEEN REQUESTED AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT. THE CUSTOMER DID NOT RETAIN THE LOT NUMBER WHICH DETERMINES THE DATE OF MANUFACTURE. SHILEY ¿LARYNGEAL MASK CLASSIFICATION IS AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY, REGULATION NUMBER 868.5110 AND IS 510K EXEMPT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE MASK WAS TOO SOFT AND DIFFICULT TO APPLY. IT WHAT ALSO REPORTED THERE WAS DESATURATION OF THE PATIENT RELATED TO THE DIFFICULTY INSERTING AND MOVING THE SECONDARY MASK WAS REPORTED. IN THIS REPORT IT WAS STATED THERE WAS ENDO-BUCCAL BLEEDING NOTICED, WITH A PATIENT POST SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768999 SHILEY LARYNGEAL MASK, SIZE 2, 10-20 KG CAE FOREFRONT MEDICAL TECHNOLOGY 33720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention