BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNOREGUARD PRO

    MDR report key: 3912752 · Received May 14, 2014

    Report

    Report Number
    1825660-2014-00829
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 14, 2014
    Manufacturer
    RANIR LLC
    Product Code
    LRK
    PMA / PMN Number
    K102118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS GIVEN BY THE CONSUMER. NO LOT CODE WAS GIVEN, NO PRODUCT WAS RETURNED FOR INVESTIGATION. CONSUMER DID NOT REPORT ANY TYPE OF INJURY. THIS INCIDENT IS BEING REPORTED AS A SEPARATION TYPE OF MALFUNCTION THAT COULD POSSIBLY LEAN TO SERIOUS INJURY. THE CONSUMER CANNOT CHOKE ON THE DEVICE BECAUSE THE CONFIGURATION OF THE MATERIAL WILL NOT LEAD TO SEALING OFF THE AIRWAYS; HOWEVER, IF A SEPARATED PART OF THE DEVICE PASSES BEYOND THE PHARYNGEAL ARCH, MEDICAL INTERVENTION MAY BE NECESSARY TO RETRIEVE THE MATERIAL.

    Description of Event or Problem · 1

    DENTIST OFFICE CALLED TO COMPLAIN THAT A PATIENT HAD A SNOREGUARD THAT DELAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288058 SNOREGUARD PRO LRK RANIR LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening