BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREBAND

    MDR report key: 6058042 · Received October 26, 2016

    Report

    Report Number
    1038758-2016-00100
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASO WAS ABLE TO OBTAIN THE LOT NUMBER AND PERFORMED TEST FOR ADHESION PROPERTIES FOR RETAINED SAMPLES IN ADDITION TO REVIEWING TEST FOR BIOCOMPATIBILITY TESTS. AS OF 10/21/2016 ASO HAS NOT RECEIVED A RESPONSE FROM THE CONSUMER REGARDING THE REQUEST FOR FURTHER INFORMATION AND RETURN OF UNUSED SAMPLES.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT AFTER REMOVING BANDAGE IT TORN HER SKIN AND CAUSED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708992 CAREBAND WATERPROOF STRONG STRIP ANTIBACTERIAL BANDAGES KGX ASO LLC ITEM # 178142 00028953

    Patients

    Seq Age Sex Outcome Treatment
    1