BEUDAMED
    FDA Adverse Event Other Summary report: N

    DOLLAR GENERAL/REXALL

    MDR report key: 3911519 · Received May 27, 2014

    Report

    Report Number
    1038758-2014-00015
    Event Type
    Other
    Date Received
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 - THE CONSUMER REPORTED THAT WHEN THE BANDAGE WAS USED ON HER NECK OVERNIGTH, HER NECK BECAME SWOLLEN AND DISCOLORED FROM PAD AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310478 DOLLAR GENERAL/REXALL FABRIC ANTIBACTERIAL XL 10 CT BANDAGE KGX ASO LLC 017276228298 00008166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other