BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE NASAL DILATOR DOUBLE BRIDGE CLEAR MED

    MDR report key: 5003082 · Received August 11, 2015

    Report

    Report Number
    1038758-2015-00061
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 11, 2015
    Manufacturer
    ASO LLC
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 - PENDING LABORATORY RESULTS OF RETAINS.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - EVALUATION OF A REPRESENTATIVE SAMPLE OF THE RELATED MEDICAL DEVICE IS SUMMARIZED.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE END USER REPORTED THAT THE DEVICE PEELED OFF THE SKIN FROM HIS NOSE WHEN HE REMOVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523922 EQUATE NASAL DILATOR DOUBLE BRIDGE CLEAR MED NASAL DILATOR LWF ASO LLC UPC 681131068420 29243

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR