BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE

    MDR report key: 4894177 · Received July 1, 2015

    Report

    Report Number
    1038758-2015-00043
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 5, 2015
    Report Date
    July 2, 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 07/02/2015 CUSTOMER HAS NOT SENT PRODUCT BACK TO LOOK AT THE LOT NUMBER ON THE BOX AND CONDUCT TESTING ON THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2015 - THE END USER REPORTED THAT SHE USED THE DEVICE 4 DAYS IN A ROW AND THE THIRD DAY IT TOOK A CHUNK OF SKIN OFF. SHE DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426583 EQUATE NASAL DILATOR LWF ASO LLC UPC 681131068420

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR